THE MOREL COMPANY HERCULES PATIENT REPOSITIONER
Report
- Report Number
- 3010388769-2024-00001
- Event Type
- Death
- Date Received
- December 16, 2024
- Date of Event
- July 28, 2024
- Report Date
- December 4, 2024
- Manufacturer
- THE MOREL COMPANY
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE MOREL COMPANY RECEIVED MEDWATCH REPORT#: MW5158427 AND UF/LMPORTER REPORT#: (B)(4). BOTH REPORTS ARE ASSOCIATED WITH THE SAME, SINGLE EVENT. THE INITIAL REPORT (MW5158427) DESCRIBED THE EVENT AND STATED THE ACTIONS BY THE CUSTOMER DETAILING HOW HERCULES WAS NOT RESPONSIBLE FOR CAUSING THE EVENT. AS SUCH, AND CONSISTENT WITH POST-SURVEILLANCE MONITORING DATA AND INTERNAL PROCESSES, NO MDR WAS FILED. THE SECOND REPORT (UF/LMPORTER REPORT#: (B)(4)) DESCRIBED A SIMILAR EVENT THAT WAS ULTIMATELY DETERMINED TO BE THE SAME EVENT. THIS MDR IS BEING FILED TO ADHERE TO INTERNAL PROCESSES AND TO PROPERLY DOCUMENT THAT BOTH REPORTS ARE ASSOCIATED WITH THE SAME EVENT AND THAT HERCULES IS NOT AT FAULT FOR CAUSING THE EVENT. THE DESCRIPTION FROM BOTH REPORTS ARE AS FOLLOWS: MDR REPORT#: MW5158427: (THE MOREL COMPANY AWARE DATE OF THIS EVENT WAS 05 SEP 2024) AN ATTEMPT TO PULL THE CPR LEVER ON A CENTRELLA BED WITH A HERCULES DEVICE INSTALLED ALLEGEDLY FAILED TO LAY THE BED FLAT AND ACTIVATE THE CPR MODE. A SAFETY REPORT INDICATED THAT THE BED WAS FOUND TO BE APPROXIMATELY AT 20 DEGREE ANGLE. THE BED WAS OBSERVED TO BE PLUGGED AND EVEN WITH THE USE OF THE REMOTE TO PLACE THE HEAD OF THE BED DOWN, ALLEGEDLY, IT DID NOT WORK. REPLICATION OF THE EVENT DID NOT DEMONSTRATE THE REPORTED PROBLEM. THE MATTRESS WAS OBSERVED TO BE LAYING ON TOP OF THE HERCULES DEVICE, RENDERING AN INCLINATION OF THE MATTRESS TO ABOUT 10 DEGREE ANGLE FROM BEDFRAME BASELINE. IT IS ALSO NOTED THE WHOLE BEDFRAME WAS IN NEUTRAL POSITION. THE CLAIM IS THAT THE INABILITY OF THE BED TO RECLINE INTERFERED WITH THE INITIATION OF CARDIO-PULMONARY RESUSCITATION. A SIMULATION OF THE EVENT WAS CONDUCTED (BY THE CUSTOMER) ON 8/5/24 AND 8/7/24 TO REPLICATE THE ISSUE IDENTIFIED IN THE REPORTED EVENT. BOTH SIMULATIONS DEMONSTRATE THAT THE HERCULES DEVICE INSTALLED ON THE BEDFRAME DID NOT AFFECT THE INITIATION OR QUALITY OF CPR, CHEST COMPRESSION, OR INTUBATION. THE CPR LEVER ON THE CENTRELLA BED ACTIVATED AS SOON AS IT WAS PULLED AND THE HEAD PART OF THE BED/ BEDFRAME RECLINED TO NEUTRAL POSITION (ZERO DEGREE) AND THE MATTRESS WAS NOTED TO BE AT 10 DEGREE INCLINE DUE TO THE HERCULES DEVICE EXPECTED PROTRUSION. THE MATTRESS WAS NOTED TO BE FIRM AND THE INCLINE FROM THE HERCULES DEVICE DID NOT AFFECT INITIATION OR QUALITY OF CPR, CHEST COMPRESSION, OR INTUBATION. WE WERE NOT ABLE TO REPLICATE THE REPORTED 20 DEGREE ANGLE ISSUE OF THE BED. REF REPORT: MW5158426. UF/LMPORTER REPORT#: (B)(4) (THE MOREL COMPANY AWARE DATE OF THIS EVENT WAS 19 NOV 2024) DESCRIBE THE EVENT OR PROBLEM: A PATIENT ADMITTED TO AN ACUTE SURGICAL INPATIENT UNIT WAS FOUND UNRESPONSIVE BY PHYSICIAN, COLD TO TOUCH. A CODE BLUE RESUSCITATION RESPONSE WAS ACTIVATED DURING WHICH AN ATTEMPT TO PULL THE CARDIOPULMONARY RESUSCITATION (CPR) LEVER ON A HILL-ROM BED EQUIPPED WITH A HERCULES BED REPOSITIONER FAILED TO LAY THE BED FLAT (UNABLE TO LOWER BELOW 20 DEGREES). THIS WAS REPORTED TO HAVE POSSIBLY IMPACTED THE ABILITY TO ACTIVATE THE CPR MODE ON THE BED. "EXCESSIVE TIME OFF CHEST" WAS REPORTED AND INTERMITTENT COMPRESSIONS WERE CORRELATED TO THE PLACEMENT OF THE LUCAS DEVICE, WHICH WAS SUBSEQUENTLY REMOVED AND REPLACED WITH MANUAL COMPRESSION. DESPITE RESUSCITATION EFFORTS, THE PATIENT EXPIRED. AS DESCRIBED ABOVE, IT HAS BEEN DETERMINED VIA FOLLOW-UP BY THE MOREL COMPANY STARTING 19 NOV 2024 THAT THE TWO AFOREMENTIONED EVENTS ARE ACTUALLY THE SAME EVENT DOCUMENTED ON SEPARATE VOLUNTARY MEDWATCH FORMS BY THE CUSTOMER ((B)(6) CENTER). SUBSEQUENTLY, DURING A 03DEC2024 AT 12:14PM EDT PHONE CONVERSATION, THE DEPUTY CHIEF BIOMEDICAL ENGINEER FOR ALL OF (B)(6) MEDICAL CENTERS COMMUNICATED THE FOLLOWING: THE TWO AFOREMENTIONED MEDWATCH EVENTS ARE THE SAME EVENT AT THE SAME USER FACILITY OCCURRING ON THE SAME DAY AND WITH THE SAME PATIENT. THEREFORE, THIS IS ACTUALLY A SINGULAR MEDWATCH EVENT DOCUMENTED AS A VOLUNTARY MEDWATCH BY THE (B)(6) ON 2 SEPARATE DATES. IT WAS ALSO CONFIRMED BY THE DEPUTY CHIEF BIOMEDICAL ENGINEER FOR ALL OF (B)(6) MEDICAL CENTERS THAT THE MOREL COMPANY'S HERCULES DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS REPORTABLE EVENT. ONCE BECOMING AWARE OF THE INITIAL MEDWATCH REPORT MW5158427 ON 05 SEP 2024, THE MOREL COMPANY CONCLUDED THROUGH ITS COMPLAINT AND MDR REPORTING QUALITY SYSTEM PROCEDURES THAT A MEDICAL DEVICE REPORT (MDR) WAS NOT REQUIRED AS NO DEATH OR INJURY WAS REPORTED AND IT WAS CONCLUDED AND CONFIRMED BY THE USER FACILITY ((B)(6) MEDICAL CENTER) THAT THE HERCULES DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT OR THE OUTCOME OF THE PATIENT. BUT, AS PREVIOUSLY INDICATED, THIS MDR IS BEING FILED TO ADHERE TO INTERNAL PROCESSES AND TO PROPERLY DOCUMENT THAT BOTH REPORTS ARE ASSOCIATED TO THE SAME EVENT AND THAT HERCULES IS NOT AT FAULT FOR CAUSING THE EVENT.
THE MOREL COMPANY RECEIVED MEDWATCH REPORT#: MW5158427 AND UF/IMPORTER REPORT#: (B)(4). BOTH REPORTS ARE ASSOCIATED WITH THE SAME, SINGLE EVENT. THE INITIAL REPORT (MW5158427) DESCRIBED THE EVENT AND STATED THE ACTIONS BY THE CUSTOMER DETAILING HOW HERCULES WAS NOT RESPONSIBLE FOR CAUSING THE EVENT. AS SUCH, AND CONSISTENT WITH POST-SURVEILLANCE MONITORING DATA AND INTERNAL PROCESSES, NO MDR WAS FILED. THE SECOND REPORT (UF/IMPORTER REPORT#: (B)(4)) DESCRIBED A SIMILAR EVENT THAT WAS ULTIMATELY DETERMINED TO BE THE SAME EVENT. THIS MDR IS BEING FILED TO ADHERE TO INTERNAL PROCESSES AND TO PROPERLY DOCUMENT THAT BOTH REPORTS ARE ASSOCIATED WITH THE SAME EVENT AND THAT HERCULES IS NOT AT FAULT FOR CAUSING THE EVENT. THE DESCRIPTION FROM BOTH REPORTS ARE AS FOLLOWS: MDR REPORT#: MW5158427: (THE MOREL COMPANY AWARE DATE OF THIS EVENT WAS 05 SEP 2024) AN ATTEMPT TO PULL THE CPR LEVER ON A CENTRELLA BED WITH A HERCULES DEVICE INSTALLED ALLEGEDLY FAILED TO LAY THE BED FLAT AND ACTIVATE THE CPR MODE. A SAFETY REPORT INDICATED THAT THE BED WAS FOUND TO BE APPROXIMATELY AT 20 DEGREE ANGLE. THE BED WAS OBSERVED TO BE PLUGGED AND EVEN WITH THE USE OF THE REMOTE TO PLACE THE HEAD OF THE BED DOWN, ALLEGEDLY, IT DID NOT WORK. REPLICATION OF THE EVENT DID NOT DEMONSTRATE THE REPORTED PROBLEM. THE MATTRESS WAS OBSERVED TO BE LAYING ON TOP OF THE HERCULES DEVICE, RENDERING AN INCLINATION OF THE MATTRESS TO ABOUT 10 DEGREE ANGLE FROM BEDFRAME BASELINE. IT IS ALSO NOTED THE WHOLE BEDFRAME WAS IN NEUTRAL POSITION. THE CLAIM IS THAT THE INABILITY OF THE BED TO RECLINE INTERFERED WITH THE INITIATION OF CARDIO-PULMONARY RESUSCITATION. A SIMULATION OF THE EVENT WAS CONDUCTED (BY THE CUSTOMER) ON (B)(6) 2024 TO REPLICATE THE ISSUE IDENTIFIED IN THE REPORTED EVENT. BOTH SIMULATIONS DEMONSTRATE THAT THE HERCULES DEVICE INSTALLED ON THE BEDFRAME DID NOT AFFECT THE INITIATION OR QUALITY OF CPR, CHEST COMPRESSION, OR INTUBATION. THE CPR LEVER ON THE CENTRELLA BED ACTIVATED AS SOON AS IT WAS PULLED AND THE HEAD PART OF THE BED/ BEDFRAME RECLINED TO NEUTRAL POSITION (ZERO DEGREE) AND THE MATTRESS WAS NOTED TO BE AT 10 DEGREE INCLINE DUE TO THE HERCULES DEVICE EXPECTED PROTRUSION. THE MATTRESS WAS NOTED TO BE FIRM AND THE INCLINE FROM THE HERCULES DEVICE DID NOT AFFECT INITIATION OR QUALITY OF CPR, CHEST COMPRESSION, OR INTUBATION. WE WERE NOT ABLE TO REPLICATE THE REPORTED 20 DEGREE ANGLE ISSUE OF THE BED. REF REPORT: MW5158426. UF/IMPORTER REPORT#: (B)(4) (THE MOREL COMPANY AWARE DATE OF THIS EVENT WAS 19 NOV 2024). DESCRIBE THE EVENT OR PROBLEM: A PATIENT ADMITTED TO AN ACUTE SURGICAL INPATIENT UNIT WAS FOUND UNRESPONSIVE BY PHYSICIAN, COLD TO TOUCH. A CODE BLUE RESUSCITATION RESPONSE WAS ACTIVATED DURING WHICH AN ATTEMPT TO PULL THE CARDIOPULMONARY RESUSCITATION (CPR) LEVER ON A HILL-ROM BED EQUIPPED WITH A HERCULES BED REPOSITIONER FAILED TO LAY THE BED FLAT (UNABLE TO LOWER BELOW 20 DEGREES). THIS WAS REPORTED TO HAVE POSSIBLY IMPACTED THE ABILITY TO ACTIVATE THE CPR MODE ON THE BED. "EXCESSIVE TIME OFF CHEST" WAS REPORTED AND INTERMITTENT COMPRESSIONS WERE CORRELATED TO THE PLACEMENT OF THE LUCAS DEVICE, WHICH WAS SUBSEQUENTLY REMOVED AND REPLACED WITH MANUAL COMPRESSION. DESPITE RESUSCITATION EFFORTS, THE PATIENT EXPIRED. AS DESCRIBED ABOVE, IT HAS BEEN DETERMINED VIA FOLLOW-UP BY THE MOREL COMPANY STARTING 19 NOV 2024 THAT THE TWO AFOREMENTIONED EVENTS ARE ACTUALLY THE SAME EVENT DOCUMENTED ON SEPARATE VOLUNTARY MEDWATCH FORMS BY THE CUSTOMER (VETERANS AFFAIRS CENTER). SUBSEQUENTLY, DURING A 03DEC2024 AT 12:14PM EDT PHONE CONVERSATION, THE DEPUTY CHIEF BIOMEDICAL ENGINEER FOR ALL OF (B)(6) MEDICAL CENTERS COMMUNICATED THE FOLLOWING: 1) THE TWO AFOREMENTIONED MEDWATCH EVENTS ARE THE SAME EVENT AT THE SAME USER FACILITY OCCURRING ON THE SAME DAY AND WITH THE SAME PATIENT. 2) THEREFORE, THIS IS ACTUALLY A SINGULAR MEDWATCH EVENT DOCUMENTED AS A VOLUNTARY MEDWATCH BY THE VETERANS AFFAIRS ON 2 SEPARATE DATES. 3) IT WAS ALSO CONFIRMED BY THE DEPUTY CHIEF BIOMEDICAL ENGINEER FOR ALL OF (B)(6) MEDICAL CENTERS THAT THE MOREL COMPANY'S HERCULES DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS REPORTABLE EVENT. ONCE BECOMING AWARE OF THE INITIAL MEDWATCH REPORT MW5158427 ON 05 SEP 2024, THE MOREL COMPANY CONCLUDED THROUGH ITS COMPLAINT AND MDR REPORTING QUALITY SYSTEM PROCEDURES THAT A MEDICAL DEVICE REPORT (MDR) WAS NOT REQUIRED AS NO DEATH OR INJURY WAS REPORTED AND IT WAS CONCLUDED AND CONFIRMED BY THE USER FACILITY (VA MEDICAL CENTER) THAT THE HERCULES DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT OR THE OUTCOME OF THE PATIENT. BUT, AS PREVIOUSLY INDICATED, THIS MDR IS BEING FILED TO ADHERE TO INTERNAL PROCESSES AND TO PROPERLY DOCUMENT THAT BOTH REPORTS ARE ASSOCIATED TO THE SAME EVENT AND THAT HERCULES IS NOT AT FAULT FOR CAUSING THE EVENT.
THE MOREL COMPANY RECEIVED MEDWATCH REPORT#: MW5158427 AND UF/LMPORTER REPORT#: (B)(4). BOTH REPORTS ARE ASSOCIATED WITH THE SAME, SINGLE EVENT. THE INITIAL REPORT (MW5158427) DESCRIBED THE EVENT AND STATED THE ACTIONS BY THE CUSTOMER DETAILING HOW HERCULES WAS NOT RESPONSIBLE FOR CAUSING THE EVENT. AS SUCH, AND CONSISTENT WITH POST-SURVEILLANCE MONITORING DATA AND INTERNAL PROCESSES, NO MDR WAS FILED. THE SECOND REPORT (UF/LMPORTER REPORT#: (B)(4)) DESCRIBED A SIMILAR EVENT THAT WAS ULTIMATELY DETERMINED TO BE THE SAME EVENT. THIS MDR IS BEING FILED TO ADHERE TO INTERNAL PROCESSES AND TO PROPERLY DOCUMENT THAT BOTH REPORTS ARE ASSOCIATED WITH THE SAME EVENT AND THAT HERCULES IS NOT AT FAULT FOR CAUSING THE EVENT. THE DESCRIPTION FROM BOTH REPORTS ARE AS FOLLOWS: MDR REPORT#: MW5158427: (THE MOREL COMPANY AWARE DATE OF THIS EVENT WAS 05 SEP 2024) AN ATTEMPT TO PULL THE CPR LEVER ON A CENTRELLA BED WITH A HERCULES DEVICE INSTALLED ALLEGEDLY FAILED TO LAY THE BED FLAT AND ACTIVATE THE CPR MODE. A SAFETY REPORT INDICATED THAT THE BED WAS FOUND TO BE APPROXIMATELY AT 20 DEGREE ANGLE. THE BED WAS OBSERVED TO BE PLUGGED AND EVEN WITH THE USE OF THE REMOTE TO PLACE THE HEAD OF THE BED DOWN, ALLEGEDLY, IT DID NOT WORK. REPLICATION OF THE EVENT DID NOT DEMONSTRATE THE REPORTED PROBLEM. THE MATTRESS WAS OBSERVED TO BE LAYING ON TOP OF THE HERCULES DEVICE, RENDERING AN INCLINATION OF THE MATTRESS TO ABOUT 10 DEGREE ANGLE FROM BEDFRAME BASELINE. IT IS ALSO NOTED THE WHOLE BEDFRAME WAS IN NEUTRAL POSITION. THE CLAIM IS THAT THE INABILITY OF THE BED TO RECLINE INTERFERED WITH THE INITIATION OF CARDIO-PULMONARY RESUSCITATION. A SIMULATION OF THE EVENT WAS CONDUCTED (BY THE CUSTOMER) ON 8/5/2024 AND 8/7/2024 TO REPLICATE THE ISSUE IDENTIFIED IN THE REPORTED EVENT. BOTH SIMULATIONS DEMONSTRATE THAT THE HERCULES DEVICE INSTALLED ON THE BEDFRAME DID NOT AFFECT THE INITIATION OR QUALITY OF CPR, CHEST COMPRESSION, OR INTUBATION. THE CPR LEVER ON THE CENTRELLA BED ACTIVATED AS SOON AS IT WAS PULLED AND THE HEAD PART OF THE BED/ BEDFRAME RECLINED TO NEUTRAL POSITION (ZERO DEGREE) AND THE MATTRESS WAS NOTED TO BE AT 10 DEGREE INCLINE DUE TO THE HERCULES DEVICE EXPECTED PROTRUSION. THE MATTRESS WAS NOTED TO BE FIRM AND THE INCLINE FROM THE HERCULES DEVICE DID NOT AFFECT INITIATION OR QUALITY OF CPR, CHEST COMPRESSION, OR INTUBATION. WE WERE NOT ABLE TO REPLICATE THE REPORTED 20 DEGREE ANGLE ISSUE OF THE BED. REF REPORT: MW5158426. UF/LMPORTER REPORT#: (B)(4) (THE MOREL COMPANY AWARE DATE OF THIS EVENT WAS 19 NOV 2024) DESCRIBE THE EVENT OR PROBLEM: A PATIENT ADMITTED TO AN ACUTE SURGICAL INPATIENT UNIT WAS FOUND UNRESPONSIVE BY PHYSICIAN, COLD TO TOUCH. A CODE BLUE RESUSCITATION RESPONSE WAS ACTIVATED DURING WHICH AN ATTEMPT TO PULL THE CARDIOPULMONARY RESUSCITATION (CPR) LEVER ON A HILL-ROM BED EQUIPPED WITH A HERCULES BED REPOSITIONER FAILED TO LAY THE BED FLAT (UNABLE TO LOWER BELOW 20 DEGREES). THIS WAS REPORTED TO HAVE POSSIBLY IMPACTED THE ABILITY TO ACTIVATE THE CPR MODE ON THE BED. "EXCESSIVE TIME OFF CHEST" WAS REPORTED AND INTERMITTENT COMPRESSIONS WERE CORRELATED TO THE PLACEMENT OF THE LUCAS DEVICE, WHICH WAS SUBSEQUENTLY REMOVED AND REPLACED WITH MANUAL COMPRESSION. DESPITE RESUSCITATION EFFORTS, THE PATIENT EXPIRED. AS DESCRIBED ABOVE, IT HAS BEEN DETERMINED VIA FOLLOW-UP BY THE MOREL COMPANY STARTING 19 NOV 2024 THAT THE TWO AFOREMENTIONED EVENTS ARE ACTUALLY THE SAME EVENT DOCUMENTED ON SEPARATE VOLUNTARY MEDWATCH FORMS BY THE CUSTOMER ((B)(6) CENTER). SUBSEQUENTLY, DURING A 03DEC2024 AT 12:14PM EDT PHONE CONVERSATION, THE DEPUTY CHIEF BIOMEDICAL ENGINEER FOR ALL OF (B)(6) MEDICAL CENTERS COMMUNICATED THE FOLLOWING: 1) THE TWO AFOREMENTIONED MEDWATCH EVENTS ARE THE SAME EVENT AT THE SAME USER FACILITY OCCURRING ON THE SAME DAY AND WITH THE SAME PATIENT. 2) THEREFORE, THIS IS ACTUALLY A SINGULAR MEDWATCH EVENT DOCUMENTED AS A VOLUNTARY MEDWATCH BY THE (B)(6) ON 2 SEPARATE DATES. 3) IT WAS ALSO CONFIRMED BY THE DEPUTY CHIEF BIOMEDICAL ENGINEER FOR ALL OF (B)(6) MEDICAL CENTERS THAT THE MOREL COMPANY'S HERCULES DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS REPORTABLE EVENT. ONCE BECOMING AWARE OF THE INITIAL MEDWATCH REPORT MW5158427 ON 05 SEP 2024, THE MOREL COMPANY CONCLUDED THROUGH ITS COMPLAINT AND MDR REPORTING QUALITY SYSTEM PROCEDURES THAT A MEDICAL DEVICE REPORT (MDR) WAS NOT REQUIRED AS NO DEATH OR INJURY WAS REPORTED AND IT WAS CONCLUDED AND CONFIRMED BY THE USER FACILITY ((B)(6) MEDICAL CENTER) THAT THE HERCULES DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT OR THE OUTCOME OF THE PATIENT. BUT, AS PREVIOUSLY INDICATED, THIS MDR IS BEING FILED TO ADHERE TO INTERNAL PROCESSES AND TO PROPERLY DOCUMENT THAT BOTH REPORTS ARE ASSOCIATED TO THE SAME EVENT AND THAT HERCULES IS NOT AT FAULT FOR CAUSING THE EVENT.
THE MOREL COMPANY RECEIVED MEDWATCH REPORT#: MW5158427 AND UF/IMPORTER REPORT#: (B)(4). BOTH REPORTS ARE ASSOCIATED WITH THE SAME, SINGLE EVENT. THE INITIAL REPORT (MW5158427) DESCRIBED THE EVENT AND STATED THE ACTIONS BY THE CUSTOMER DETAILING HOW HERCULES WAS NOT RESPONSIBLE FOR CAUSING THE EVENT. AS SUCH, AND CONSISTENT WITH POST-SURVEILLANCE MONITORING DATA AND INTERNAL PROCESSES, NO MDR WAS FILED. THE SECOND REPORT (UF/IMPORTER REPORT#: (B)(4)) DESCRIBED A SIMILAR EVENT THAT WAS ULTIMATELY DETERMINED TO BE THE SAME EVENT. THIS MDR IS BEING FILED TO ADHERE TO INTERNAL PROCESSES AND TO PROPERLY DOCUMENT THAT BOTH REPORTS ARE ASSOCIATED WITH THE SAME EVENT AND THAT HERCULES IS NOT AT FAULT FOR CAUSING THE EVENT. THE DESCRIPTION FROM BOTH REPORTS ARE AS FOLLOWS: MDR REPORT#: MW5158427: (THE MOREL COMPANY AWARE DATE OF THIS EVENT WAS 05 SEP 2024) AN ATTEMPT TO PULL THE CPR LEVER ON A CENTRELLA BED WITH A HERCULES DEVICE INSTALLED ALLEGEDLY FAILED TO LAY THE BED FLAT AND ACTIVATE THE CPR MODE. A SAFETY REPORT INDICATED THAT THE BED WAS FOUND TO BE APPROXIMATELY AT 20 DEGREE ANGLE. THE BED WAS OBSERVED TO BE PLUGGED AND EVEN WITH THE USE OF THE REMOTE TO PLACE THE HEAD OF THE BED DOWN, ALLEGEDLY, IT DID NOT WORK. REPLICATION OF THE EVENT DID NOT DEMONSTRATE THE REPORTED PROBLEM. THE MATTRESS WAS OBSERVED TO BE LAYING ON TOP OF THE HERCULES DEVICE, RENDERING AN INCLINATION OF THE MATTRESS TO ABOUT 10 DEGREE ANGLE FROM BEDFRAME BASELINE. IT IS ALSO NOTED THE WHOLE BEDFRAME WAS IN NEUTRAL POSITION. THE CLAIM IS THAT THE INABILITY OF THE BED TO RECLINE INTERFERED WITH THE INITIATION OF CARDIO-PULMONARY RESUSCITATION. A SIMULATION OF THE EVENT WAS CONDUCTED (BY THE CUSTOMER) ON (B)(6) 2024 TO REPLICATE THE ISSUE IDENTIFIED IN THE REPORTED EVENT. BOTH SIMULATIONS DEMONSTRATE THAT THE HERCULES DEVICE INSTALLED ON THE BEDFRAME DID NOT AFFECT THE INITIATION OR QUALITY OF CPR, CHEST COMPRESSION, OR INTUBATION. THE CPR LEVER ON THE CENTRELLA BED ACTIVATED AS SOON AS IT WAS PULLED AND THE HEAD PART OF THE BED/ BEDFRAME RECLINED TO NEUTRAL POSITION (ZERO DEGREE) AND THE MATTRESS WAS NOTED TO BE AT 10 DEGREE INCLINE DUE TO THE HERCULES DEVICE EXPECTED PROTRUSION. THE MATTRESS WAS NOTED TO BE FIRM AND THE INCLINE FROM THE HERCULES DEVICE DID NOT AFFECT INITIATION OR QUALITY OF CPR, CHEST COMPRESSION, OR INTUBATION. WE WERE NOT ABLE TO REPLICATE THE REPORTED 20 DEGREE ANGLE ISSUE OF THE BED. REF REPORT: MW5158426. UF/IMPORTER REPORT#: (B)(4) (THE MOREL COMPANY AWARE DATE OF THIS EVENT WAS 19 NOV 2024) DESCRIBE THE EVENT OR PROBLEM: A PATIENT ADMITTED TO AN ACUTE SURGICAL INPATIENT UNIT WAS FOUND UNRESPONSIVE BY PHYSICIAN, COLD TO TOUCH. A CODE BLUE RESUSCITATION RESPONSE WAS ACTIVATED DURING WHICH AN ATTEMPT TO PULL THE CARDIOPULMONARY RESUSCITATION (CPR) LEVER ON A HILL-ROM BED EQUIPPED WITH A HERCULES BED REPOSITIONER FAILED TO LAY THE BED FLAT (UNABLE TO LOWER BELOW 20 DEGREES). THIS WAS REPORTED TO HAVE POSSIBLY IMPACTED THE ABILITY TO ACTIVATE THE CPR MODE ON THE BED. "EXCESSIVE TIME OFF CHEST" WAS REPORTED AND INTERMITTENT COMPRESSIONS WERE CORRELATED TO THE PLACEMENT OF THE LUCAS DEVICE, WHICH WAS SUBSEQUENTLY REMOVED AND REPLACED WITH MANUAL COMPRESSION. DESPITE RESUSCITATION EFFORTS, THE PATIENT EXPIRED. AS DESCRIBED ABOVE, IT HAS BEEN DETERMINED VIA FOLLOW-UP BY THE MOREL COMPANY STARTING 19 NOV 2024 THAT THE TWO AFOREMENTIONED EVENTS ARE ACTUALLY THE SAME EVENT DOCUMENTED ON SEPARATE VOLUNTARY MEDWATCH FORMS BY THE CUSTOMER (VETERANS AFFAIRS CENTER). SUBSEQUENTLY, DURING A 03DEC2024 AT 12:14PM EDT PHONE CONVERSATION, THE DEPUTY CHIEF BIOMEDICAL ENGINEER FOR ALL OF (B)(6) VA MEDICAL CENTERS COMMUNICATED THE FOLLOWING: 1) THE TWO AFOREMENTIONED MEDWATCH EVENTS ARE THE SAME EVENT AT THE SAME USER FACILITY OCCURRING ON THE SAME DAY AND WITH THE SAME PATIENT. 2) THEREFORE, THIS IS ACTUALLY A SINGULAR MEDWATCH EVENT DOCUMENTED AS A VOLUNTARY MEDWATCH BY THE VETERANS AFFAIRS ON 2 SEPARATE DATES. 3) IT WAS ALSO CONFIRMED BY THE DEPUTY CHIEF BIOMEDICAL ENGINEER FOR ALL OF (B)(6) MEDICAL CENTERS THAT THE MOREL COMPANY'S HERCULES DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS REPORTABLE EVENT. ONCE BECOMING AWARE OF THE INITIAL MEDWATCH REPORT MW5158427 ON 05 SEP 2024, THE MOREL COMPANY CONCLUDED THROUGH ITS COMPLAINT AND MDR REPORTING QUALITY SYSTEM PROCEDURES THAT A MEDICAL DEVICE REPORT (MDR) WAS NOT REQUIRED AS NO DEATH OR INJURY WAS REPORTED AND IT WAS CONCLUDED AND CONFIRMED BY THE USER FACILITY (VA MEDICAL CENTER) THAT THE HERCULES DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT OR THE OUTCOME OF THE PATIENT. BUT, AS PREVIOUSLY INDICATED, THIS MDR IS BEING FILED TO ADHERE TO INTERNAL PROCESSES AND TO PROPERLY DOCUMENT THAT BOTH REPORTS ARE ASSOCIATED TO THE SAME EVENT AND THAT HERCULES IS NOT AT FAULT FOR CAUSING THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1485950 | THE MOREL COMPANY HERCULES PATIENT REPOSITIONER | HERCULES | FNL | THE MOREL COMPANY | DFSA3N | NOT PROVIDED BY USER FACILITY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Prefer Not To Disclose | Death |