HAMILTON-C6
Report
- Report Number
- 3001421318-2023-04108
- Event Type
- Death
- Date Received
- December 7, 2023
- Date of Event
- December 6, 2023
- Report Date
- July 31, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- PMA / PMN Number
- K201658
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT AS A MALFUNCTION OF THE DEVICE COULD BE IDENTIFIED. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT. DSI EVENT. MEDICAL INTERVENTION: THE EVENT OCCURRED, WHILE THE PATIENT WAS IN HOSPITAL FOR THE TREATMENT FOR AN UNRUPTURED ANEURYSM. SHORTLY AFTER THIS EVENT, THE PATIENT HAD A CARDIAC ARREST. THE RESUSCITATION MEASURES WERE DISCONTINUED AT THE REQUEST OF THE FAMILY MEMBERS AND THE PATIENT DIED. THIS IS CONSIDERED AS REPORTABLE. A TECHNICAL INVESTIGATION WAS OPENED IN ORDER TO CAPTURE THE ANALYTICAL RESULTS. THE DEVICE VENTILATION STOPPED DUE TO AN APPLICATION PROGRAM PROBLEM IN COMBINATION WITH EXTERNAL FLOW SENSOR FAILURE AND SUCTIONING TOOL. THE VENTILATION OF THE PATIENT WAS NOT REACTIVATED IMMEDIATELY AFTER THE SUCTIONING MANEUVER WAS FINISHED. THERE WERE NO ENTRIES IN THE LOG FILES THAT INDICATED THAT THE VENTILATION HAD STOPPED. THE DEVICE USER INTERFACE 1) DISPLAYED ON THE MONITOR SCREEN THE STATUS VENTILATION OFF BY THE ABSENCE OF LUNG DILATATION MOVEMENTS AND 2) THE STATUS INDICATOR (PN 160668) ON THE DEVICE FRONT WAS NOT BLINKING ON/OFF EITHER, AS IT DOES DURING VENTILATION. THIS WAS REPORTEDLY NOTED BY HOSPITAL STAFF. THE ROOT CAUSE FOR THE APPEARANCE OF THE FLOW SENSOR FAILURE WAS A FALSE-POSITIVE MESSAGE DUE TO A KNOWN APPLICATION PROGRAM PROBLEM, WHICH WAS SOLVED WITH THE INTRODUCTION OF SW1.2.1 AND HIGHER. A RECONNECTION OF THE PATIENT AFTER A SUCTIONING MANEUVER IS NOW DETECTED, EVEN IF THE PROXIMAL FLOW SENSOR IS NOT FUNCTIONING CORRECTLY. A CORRECTION MUST INCLUDE INSTALLATION OF A CURRENT SOFTWARE UPDATE. THE FOLLOWING CAPA WAS OPENED CONCERNING THIS EVENT: "2023_12_0105 - C6 SW FAILURE WITH DSI PATIENT". BASED ON THE RESULTS OF THIS REPORT, IT CANNOT BE DETERMINED, WHETHER THE MISSING VENTILATION TIME PERIOD WOULD HAVE LED TO A DIFFERENT OUTCOME FOR THE PATIENT.
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT AS A MALFUNCTION OF THE DEVICE COULD BE IDENTIFIED. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT. DSI EVENT. MEDICAL INTERVENTION: THE EVENT OCCURRED, WHILE THE PATIENT WAS IN HOSPITAL FOR THE TREATMENT FOR AN UNRUPTURED ANEURYSM. SHORTLY AFTER THIS EVENT, THE PATIENT HAD A CARDIAC ARREST. THE RESUSCITATION MEASURES WERE DISCONTINUED AT THE REQUEST OF THE FAMILY MEMBERS AND THE PATIENT DIED. THIS IS CONSIDERED AS REPORTABLE. A TECHNICAL INVESTIGATION WAS OPENED IN ORDER TO CAPTURE THE ANALYTICAL RESULTS. THE DEVICE VENTILATION STOPPED DUE TO AN APPLICATION PROGRAM PROBLEM IN COMBINATION WITH EXTERNAL FLOW SENSOR FAILURE AND SUCTIONING TOOL. THE VENTILATION OF THE PATIENT WAS NOT REACTIVATED IMMEDIATELY AFTER THE SUCTIONING MANEUVER WAS FINISHED. THERE WERE NO ENTRIES IN THE LOG FILES THAT INDICATED THAT THE VENTILATION HAD STOPPED. THE DEVICE USER INTERFACE 1) DISPLAYED ON THE MONITOR SCREEN THE STATUS VENTILATION OFF BY THE ABSENCE OF LUNG DILATATION MOVEMENTS AND 2) THE STATUS INDICATOR (PN 160668) ON THE DEVICE FRONT WAS NOT BLINKING ON/OFF EITHER, AS IT DOES DURING VENTILATION. THIS WAS REPORTEDLY NOTED BY HOSPITAL STAFF. THE ROOT CAUSE FOR THE APPEARANCE OF THE FLOW SENSOR FAILURE WAS A FALSE-POSITIVE MESSAGE DUE TO A KNOWN APPLICATION PROGRAM PROBLEM, WHICH WAS SOLVED WITH THE INTRODUCTION OF SW1.2.1 AND HIGHER. A RECONNECTION OF THE PATIENT AFTER A SUCTIONING MANEUVER IS NOW DETECTED, EVEN IF THE PROXIMAL FLOW SENSOR IS NOT FUNCTIONING CORRECTLY. A CORRECTION MUST INCLUDE INSTALLATION OF A CURRENT SOFTWARE UPDATE. THE FOLLOWING CAPA WAS OPENED CONCERNING THIS EVENT: "2023_12_0105 - C6 SW FAILURE WITH DSI PATIENT". BASED ON THE RESULTS OF THIS REPORT, IT CANNOT BE DETERMINED, WHETHER THE MISSING VENTILATION TIME PERIOD WOULD HAVE LED TO A DIFFERENT OUTCOME FOR THE PATIENT. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 2 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION AS REQUESTED.
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: CASE UNDER INVESTIGATION UNDER CER 144597.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: ON (B)(6), AT APPROXIMATELY 21:48, A FLOW SENSOR FAILURE ALARM OCCURRED, AND A SUCTION OPERATION WAS PERFORMED TO TREAT THE PROBLEM. HOSPITAL STAFF STATED THAT SINCE THAT TIME, GAS STOPPED FLOWING FROM THE C6 INSPIRATION. THEY ALSO STATED THAT THE PRESSURE AND FLOW WAVEFORMS STOPPED APPEARING ON THE SCREEN AS WELL. THE PATIENT'S CONDITION THEN SUDDENLY CHANGED, AND A REPLACEMENT C6 WAS PREPARED, BUT THE PATIENT LATER WENT INTO CARDIAC ARREST. THE DEFECTIVE C6 WAS KEPT ON STANDBY SCREEN UNTIL THE NEXT DAY. ON (B)(6), AROUND 8:50 A.M., (B)(6) STAFF VISITED THE HOSPITAL AND CHECKED THE VENTILATION OPERATION OF C6, WHICH SEEMED TO BE WORKING FINE.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: ON DECEMBER 6, AT APPROXIMATELY 21:48, A FLOW SENSOR FAILURE ALARM OCCURRED, AND A SUCTION OPERATION WAS PERFORMED TO TREAT THE PROBLEM. HOSPITAL STAFF STATED THAT SINCE THAT TIME, GAS STOPPED FLOWING FROM THE C6 INSPIRATION. THEY ALSO STATED THAT THE PRESSURE AND FLOW WAVEFORMS STOPPED APPEARING ON THE SCREEN AS WELL. THE PATIENT'S CONDITION THEN SUDDENLY CHANGED, AND A REPLACEMENT C6 WAS PREPARED, BUT THE PATIENT LATER WENT INTO CARDIAC ARREST. THE DEFECTIVE C6 WAS KEPT ON STANDBY SCREEN UNTIL THE NEXT DAY. ON DECEMBER 7, AROUND 8:50 A.M., NK STAFF VISITED THE HOSPITAL AND CHECKED THE VENTILATION OPERATION OF C6, WHICH SEEMED TO BE WORKING FINE.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: ON DECEMBER 6, AT APPROXIMATELY 21:48, A FLOW SENSOR FAILURE ALARM OCCURRED, AND A SUCTION OPERATION WAS PERFORMED TO TREAT THE PROBLEM. HOSPITAL STAFF STATED THAT SINCE THAT TIME, GAS STOPPED FLOWING FROM THE C6 INSPIRATION. THEY ALSO STATED THAT THE PRESSURE AND FLOW WAVEFORMS STOPPED APPEARING ON THE SCREEN AS WELL. THE PATIENT'S CONDITION THEN SUDDENLY CHANGED, AND A REPLACEMENT C6 WAS PREPARED, BUT THE PATIENT LATER WENT INTO CARDIAC ARREST. THE DEFECTIVE C6 WAS KEPT ON STANDBY SCREEN UNTIL THE NEXT DAY. ON DECEMBER 7, AROUND 8:50 A.M., NK STAFF VISITED THE HOSPITAL AND CHECKED THE VENTILATION OPERATION OF C6, WHICH SEEMED TO BE WORKING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 199942 | HAMILTON-C6 | HAMILTON-C6 | CBK | HAMILTON MEDICAL AG | 160021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |