AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
Report
- Report Number
- 3003793491-2014-00257
- Event Type
- Injury
- Date Received
- May 23, 2014
- Date of Event
- April 27, 2014
- Report Date
- April 30, 2014
- Manufacturer
- ZOLL CIRCULATION, INC
- Product Code
- DRM
- PMA / PMN Number
- K112998
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- NURSE
Narratives
CUSTOMER INDICATED THAT THE AUTOPULSE HAS BEEN TAKEN OUT OF SERVICE AND THAT THE ISSUE WAS CONTINUOUS. ZOLL HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.
IN ADDITION, PLEASE NOTE THAT THE INITIAL REPORT STATED THAT THE LIFEBAND SEEMED TWISTED. PER THE ADDITIONAL INFORMATION PROVIDED, THE LIFEBAND WAS NOT VISIBLY TWISTED AT THE TIME OF THE EVENT BUT WAS FOUND UPON INSPECTION AFTER TREATMENT. THE AUTOPULSE PLATFORM AND LIFEBAND WERE RETURNED TO ZOLL FOR INVESTIGATION. INVESTIGATION RESULTS FOR THE RETURNED PLATFORM IS AS FOLLOWS: VISUAL INSPECTION OF THE PLATFORM WAS PERFORMED AND NO DAMAGES WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED AND NO ISSUES WERE NOTED. THE PLATFORM WAS RUN WITH A 95% PATIENT TEST FIXTURE AND A TEST BATTERY FOR ONE HOUR WITH NO FAULTS OR ERRORS OBSERVED. LOAD CELL CHARACTERIZATION WAS PERFORMED AND BOTH LOAD CELLS WERE REPORTING NORMALLY AND FUNCTIONING AS INTENDED. THE REPORTED USER ADVISORY (UA) 41 (PATIENT TEMPERATURE SENSOR FAILURE) COULD NOT BE REPRODUCED DURING FUNCTIONAL EVALUATION. INSPECTION OF THE DEVICE FURTHER CONFIRMED THAT THE TEMPERATURE SENSOR WAS FUNCTIONING AS INTENDED. A PROBABLE CAUSE FOR THE REPORTED UA 41 FAULTS WAS EXPOSURE OF THE DEVICE TO A HIGH TEMPERATURE ENVIRONMENT FOR AN EXTENDED PERIOD OF TIME, SUBSEQUENTLY INCREASING THE INTERNAL TEMPERATURE OF THE AUTOPULSE AND CAUSING THE UA 41 MESSAGE. IF THE AUTOPULSE IS EXPOSED TO HIGH TEMPERATURE FOR AN EXTENDED PERIOD OF TIME, THE AUTOPULSE PLATFORM WILL PRODUCE A UA 41 MESSAGE (AS OBSERVED BY THE CUSTOMER). ALTHOUGH THE EVENT DATE THAT WAS REPORTED TO ZOLL WAS (B)(6) 2014, DATA IN THE ARCHIVE SUGGESTS THAT THE LAST DATE THAT THE AUTOPULSE PLATFORM WAS DEPLOYED ON A PATIENT WAS (B)(6) 2014. A REVIEW OF THE ARCHIVE DATA SHOWS THAT THE REPORTED UA 41 FAULT OCCURRED MULTIPLE TIMES ON (B)(6) 2014. THERE WERE NO UA 41 FAULTS OBSERVED ON THE REPORTED EVENT DATE OF (B)(6) 2014. IN ADDITION TO THE UA 41 FAULTS, UA 17 (MAX MOTOR ON-TIME EXCEEDED DURING ACTIVE OPERATION) AND UA 19 (MAX LOAD APPLIED EXCEEDED) FAULTS ALSO OCCURRED ON (B)(6) 2014. ARCHIVE DATA SUGGESTS THAT THESE TWO FAULTS OCCURRED DUE TO USE OF THE PLATFORM ON A VERY LARGE, STIFF, AND/OR DIFFICULT TO COMPRESS PATIENT. FOR THE REPORTED EVENT DATE OF (B)(6) 2014, A UA 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) FAULT WAS OBSERVED IN THE ARCHIVE. DATA SHOWS THAT THIS DID NOT OCCUR WHILE THE PLATFORM WAS IN ACTIVE OPERATION ON A PATIENT. THE FAULT LIKELY OCCURRED WHILE THE CUSTOMER WAS ATTEMPTING TO STORE THE AUTOPULSE PLATFORM WITH THE LIFEBAND INSTALLED IN A READY POSITION. BASED ON THE INVESTIGATION, THERE WERE NO PARTS IDENTIFIED FOR REPLACEMENT. INVESTIGATION RESULTS FOR THE RETURNED AUTOPULSE LIFEBAND IS AS FOLLOWS: WITH THE CONDITION OF THE UNIT AS RECEIVED, FUNCTIONAL TESTING OF THE RETURNED LIFEBAND COULD NOT BE PERFORMED. THE UNIT WAS RECEIVED WITH MORE DAMAGE THAN WHAT WAS REPORTED: I.E. TORN GUARD CAP LINERS, MULTIPLE CREASES AND TWISTS ON THE SURFACE OF THE BELT GUARD AND THE INNER BELT FOLDING OVER ITSELF AND JAMMING WITH THE CLOTH'S OUTER COVER. THE CUSTOMER'S REPORTED COMPLAINT OF A TWISTED LIFEBAND WAS CONFIRMED VIA VISUAL INSPECTION. FUNCTIONAL TESTING WITH A NEW LIFEBAND ON THE AUTOPULSE COULD NOT REPLICATE THE REPORTED ISSUE AS THE LIFEBAND FUNCTIONED AS INTENDED. THE DAMAGES INCURRED BY THE LIFEBAND MAY HAVE BEEN A RESULT OF USER ERROR DURING INSTALLATION OF THE LIFEBAND ONTO THE AUTOPULSE PLATFORM. IN SUMMARY, THE REPORTED COMPLAINT OF UA 41 FAULTS WAS CONFIRMED THROUGH ARCHIVE REVIEW TO HAVE OCCURRED ON (B)(6) 2014. INSPECTION OF THE DEVICE CONFIRMED THAT THE TEMPERATURE SENSOR WAS FUNCTIONING AS INTENDED. A PROBABLE CAUSE FOR THE REPORTED UA 41 FAULTS WAS EXPOSURE OF THE DEVICE TO A HIGH TEMPERATURE ENVIRONMENT FOR AN EXTENDED PERIOD OF TIME, SUBSEQUENTLY INCREASING THE INTERNAL TEMPERATURE OF THE AUTOPULSE. TWO ADDITIONAL UA FAULTS (UA 17 AND UA 19) WERE ALSO OBSERVED ON (B)(6) 2014 AND ATTRIBUTED TO USE OF THE PLATFORM ON A VERY LARGE, STIFF, AND/OR DIFFICULT TO COMPRESS PATIENT. THE UA17 AND UA19 MESSAGES ARE EXPECTED IF THE AUTOPULSE IS DEPLOYED ON PATIENT THAT IS VERY LARGE, STIFF, AND/OR DIFFICULT TO COMPRESS PATIENT. ARCHIVE DATA FROM (B)(6) 2014 SHOWED THAT A UA 18 FAULT OCCUR, HOWEVER, NOT DURING PATIENT USE. THE FAULT LIKELY OCCURRED WHILE THE CUSTOMER WAS ATTEMPTING TO STORE THE AUTOPULSE PLATFORM WITH THE LIFEBAND INSTALLED IN A READY POSITION. EVALUATION OF THE PLATFORM INDICATED THAT THE PLATFORM PASSED ALL TESTING CRITERIA AND DID NOT REQUIRE ANY PART REPLACEMENTS. THE AUTOPULSE PLATFORM PERFORMED AS INTENDED. THE REPORTED ISSUE OF THE LIFEBAND BECOMING TWISTED IS CONSIDERED UNRELATED TO THE REPORTED UA 41 FAULTS. INSPECTION BY THE SUPER USERS REVEALED THAT THE LIFEBAND WAS LOOSE WHEN IT WAS PULLED UP AND THE BAND PULLED TO THE RIGHT SIDE. THE PROTECTIVE PAPER AROUND THE MEYLAR BAND WAS LOOSE ON BOTH SIDES AND WAS TANGLED ON THE RIGHT SIDE OF THE BELT HOLDER. PLEASE NOTE THAT THE AUTOPULSE USER GUIDE CAUTIONS USERS TO "MAKE SURE THAT THE LIFEBAND IS NOT TWISTED BEFORE AUTOMATIC COMPRESSIONS BEGIN." THIS IS DONE BY MAKING SURE THAT BOTH FREE ENDS OF THE LIFEBAND ARE ORIENTED FLAT AND AWAY FROM THE AUTOPULSE PLATFORM. INVESTIGATION RESULTS FOUND THAT THE DAMAGES INCURRED BY THE LIFEBAND MAY HAVE BEEN A RESULT OF USER ERROR DURING INSTALLATION OF THE LIFEBAND ONTO THE AUTOPULSE PLATFORM. THE USER GUIDE INSTRUCTS USERS TO "MAKE SURE THAT THE YELLOW UPPER EDGE OF THE LIFEBAND IS ALIGNED WITH THE PATIENT'S ARMPITS, AND IS DIRECTLY OVER THE YELLOW LINE ON THE AUTOPULSE PLATFORM. ALSO MAKE SURE THAT THERE ARE NO OBSTRUCTIONS, SUCH AS CLOTHING, STRAPS OR EQUIPMENT, WITH THE BANDS." "FAILURE TO PROPERLY POSITION THE LIFEBAND AT THE PATIENT'S ARMPIT LINE MAY CAUSE INJURY TO THE PATIENT." THE USER GUIDE ALSO WARNS USERS THAT "OPERATING THE AUTOPULSE ON A PATIENT FOR EXTENDED PERIODS OF TIME MAY RESULT IN MINOR SKIN IRRITATION TO THE PATIENT." PLEASE NOTE THAT MANUAL CPR WAS PERFORMED AFTER USE OF THE AUTOPULSE. SKIN ABRASIONS TO THE CHEST IS A KNOWN INJURY WITH BOTH MANUAL AND MECHANICAL CPR.
IT WAS REPORTED THAT DURING A PATIENT EVENT, THE AUTOPULSE PLATFORM WORKED NORMALLY FOR 6 MINUTES AND THEN DISPLAYED AN ERROR CODE 41 (PATIENT TEMPERATURE SENSOR FAILURE) MESSAGE. THE USER PULLED UP THE LIFEBAND BUT NOTHING HAPPENED. THE PLATFORM WAS POWER-CYCLED (TURNED OFF THEN ON) AND WORKED FOR ABOUT 6 MINUTES BUT THEN DISPLAYED AN ERROR CODE 41 MESSAGE. CUSTOMER INDICATED THAT THE LIFEBAND SEEMED TWISTED. NO FURTHER INFORMATION WAS PROVIDED. PATIENT EXPIRED BUT THE CAUSE OF DEATH WAS NOT RELATED TO THE DEVICE. MANUFACTURER HAS REQUESTED ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.
ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER: THE INITIAL CALL WAS FOR A (B)(6) MALE PATIENT WEIGHING (B)(6) IN CARDIAC ARREST. THE INCIDENT OCCURRED AT THE PATIENT'S HOME. THE ARREST WAS WITNESSED BY THE PATIENT'S WIFE. PATIENT WAS DOWN FOR APPROXIMATELY 4 MINUTES PRIOR TO EMS ARRIVAL. BYSTANDER CPR WAS PERFORMED BY A NEIGHBOR WHO WAS A NURSE (EXACT LENGTH OF TIME WAS NOT PROVIDED). THE AUTOPULSE PLATFORM WAS DEPLOYED WITHOUT ANY ISSUES. THE PLATFORM PERFORMED COMPRESSIONS FOR ABOUT 6 MINUTES AND WAS THEN PAUSED FOR ANALYSIS OF THE DEFIBRILLATOR. UPON RESTART OF THE PLATFORM, A USER ADVISORY 41 WAS DISPLAYED. THE CREW PULLED UP ON THE LIFEBAND BUT THE ADVISORY MESSAGE DID NOT CLEAR AND THE PLATFORM CONTINUED TO DISPLAY "PULL UP ON LIFEBAND". THE PLATFORM WAS RESTARTED AFTER POWERING THE DEVICE ON/OFF 6-7 TIMES. THE PLATFORM RAN FOR ANOTHER 6 MINUTES BUT THE SAME UA 41 MESSAGE DISPLAYED. THE LIFEBAND WAS NOT VISIBLY TWISTED AT THE TIME OF THE EVENT. CREW IMMEDIATELY REVERTED TO MANUAL CPR (EXACT LENGTH OF TIME WAS NOT PROVIDED). PATIENT WAS TRANSPORTED TO A HOSPITAL THAT WAS 9 KM AWAY IN 15 MINUTES. MANUAL CPR WAS CONTINUED DURING TRANSPORT AND AT THE HOSPITAL (EXACT LENGTH OF TIME WAS NOT PROVIDED). A CARDIAC ULTRASOUND WAS PERFORMED AT THE HOSPITAL; HOWEVER, THE RESULTS WERE NOT PROVIDED. THE CREW AND "SUPER USER" COULD NOT PROVIDE THE DATE AND CAUSE OF DEATH. IN ADDITION, THE "SUPER USER" IS UNWILLING TO PROVIDE PATIENT SPECIFIC INFORMATION. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE LIFEBAND WAS INSPECTED BY THE CREW BACK AT THEIR SITE AND NOTHING UNUSUAL WAS FOUND. ONE CREW MEMBER INDICATED THAT WHEN THE LIFEBAND WAS REMOVED AT THE END OF TREATMENT, SMALL "BURN MARKS" (ABRASIONS) WERE OBSERVED ON THE PATIENT'S CHEST. FURTHER INSPECTION BY THE "SUPER USER" REVEALED THAT THE LIFEBAND WAS LOOSE WHEN IT WAS PULLED UP AND THE BAND PULLED TO THE RIGHT SIDE. THE PROTECTIVE PAPER AROUND THE MEYLAR BAND WAS LOOSE ON BOTH SIDES AND WAS TANGLED ON THE RIGHT SIDE OF THE BELT HOLDER. "SUPER USER" ATTRIBUTES THE OBSERVED "BURN MARKS" TO THE AUTOPULSE LIFEBAND'S MOVEMENT DURING TREATMENT. THE PLATFORM WAS ALSO TESTED WITH A MANNEQUIN AND PERFORMED 3 COMPRESSIONS. THE PLATFORM THEN STOPPED AND DISPLAYED A USER ADVISORY 19 (MAX APPLIED LOAD EXCEEDED) MESSAGE. THE "SUPER USER" SUSPECTED THAT THE MANNEQUIN WAS TOO LIGHT AND WAS NOT RESTING ON THE PRESSURE SENSOR. THE SENSOR PLATE WAS PRESSED; HOWEVER, THE PLATFORM DISPLAYED A USER ADVISORY 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) MESSAGE. PLEASE NOTE THAT "SUPER USERS" ARE THE ONES WHO HAVE BEEN EDUCATED WITH A MORE IN-DEPTH KNOWLEDGE IN THE SERVICE OF THE AUTOPULSE AS WELL AS CONDUCTING TRAINING AT LOCAL STATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308529 | AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 | CARDIAC CHEST COMPRESSOR | DRM | ZOLL CIRCULATION, INC | MODEL 100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |