HAMILTON MEDICAL AG
Report
- Report Number
- 3001421318-2024-01696
- Event Type
- Death
- Date Received
- July 15, 2024
- Date of Event
- June 27, 2024
- Report Date
- November 26, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800747
- PMA / PMN Number
- K181216
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). FOLLOW-UP NR. 1 INFORMATION: CORRECTION: FIELD D4 - UDI INFORMATION UPDATED. ADDITIONAL INFORMATION: FIELD B4, G3, G6, H2, H4, H6, H11 - THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AS THE LOCAL POLICE IS BLOCKING DEVICE AND THEREFORE NO INVESTIGATION RESULT IS AVAILABLE. THE LOG FILES ARE NOT AVAILABLE. IT WAS REPORTED THAT THE DEVICE ALARMED FOR 'DISCONNECTION' DURING VENTILATION AT THE TIME OF INCIDENT WHICH INVOLVED THE PATIENT DEATH ON (B)(6) 2024 AT 22:00. BY THE TIME DEVICE LOGS WERE DOWNLOADED, THE EVENT LOGS OF THE TIME OF INCIDENT HAD BEEN OVERWRITTEN. IT WAS REPORTED THAT THIS DEVICE WAS IN USE ON THIS PATIENT SINCE APRIL 2024, HOWEVER, NO CLEAR RECORD OF SETTINGS IS NOW AVAILABLE. THEREFORE, NO FINAL CONCLUSION CAN BE MADE CONCERNING THE OCCURRED EVENT. IF FURTHER INFORMATION IS RECEIVED, THE INVESTIGATION WILL BE UPDATED AND A FOLLOW-UP REPORT WILL BE PROVIDED. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 2 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. WITHIN THE UDI-PI PROJECT, HAMILTON MEDICAL REALIZED THAT THE REPORTED DEVICE (BRAND NAME: HAMILTON-C1; VERSION / MODEL / CATALOG NUMBER: 161003) IN THE PRESENT MDR IS NOT FULFILLING THE CRITERIA OF SIMILARITY FOR A DEVICE MARKETED IN THE U.S., THEREFORE THIS EVENT IS NO LONGER CONSIDERED REPORTABLE TO FDA AND NO UDI-PI IS GOING TO BE PROVIDED.
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). FOLLOW-UP NR. 1 INFORMATION: CORRECTION: FIELD D4 - UDI INFORMATION UPDATED. ADDITIONAL INFORMATION: FIELD B4, G3, G6, H2, H4, H6, H11 - THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AS THE LOCAL POLICE IS BLOCKING DEVICE AND THEREFORE NO INVESTIGATION RESULT IS AVAILABLE. THE LOG FILES ARE NOT AVAILABLE. IT WAS REPORTED THAT THE DEVICE ALARMED FOR 'DISCONNECTION' DURING VENTILATION AT THE TIME OF INCIDENT WHICH INVOLVED THE PATIENT DEATH ON (B)(6) 2024 AT 22:00. BY THE TIME DEVICE LOGS WERE DOWNLOADED, THE EVENT LOGS OF THE TIME OF INCIDENT HAD BEEN OVERWRITTEN. IT WAS REPORTED THAT THIS DEVICE WAS IN USE ON THIS PATIENT SINCE (B)(6) 2024, HOWEVER, NO CLEAR RECORD OF SETTINGS IS NOW AVAILABLE. THEREFORE, NO FINAL CONCLUSION CAN BE MADE CONCERNING THE OCCURRED EVENT. IF FURTHER INFORMATION IS RECEIVED, THE INVESTIGATION WILL BE UPDATED AND A FOLLOW-UP REPORT WILL BE PROVIDED.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: ON (B)(6) 2024, AT APPROXIMATELY 10:00 P.M., A "DISCONNECTION ON XXXXXX" OCCURRED. IT IS UNKNOWN WHETHER IT WAS ON THE PATIENT SIDE OR THE VENTILATOR SIDE. THE PATIENT SUBSEQUENTLY DIED. THE HOSPITAL DID NOT APPEAR TO DETERMINE THAT THERE WAS A PROBLEM WITH C1 AND THAT THE PATIENT DIED. AFTER THIS EVENT OCCURRED, THE POLICE ENTERED THE HOSPITAL TO CHECK THE OPERATION OF C1. LATER, ON (B)(6), THE HOSPITAL STAFF CONTACTED (B)(6) LOCAL STAFF TO RETRIEVE THE LOGS FROM C1. HOWEVER, THE LOG AT THAT TIME HAD BEEN LOST. ON (B)(6), AT THE REQUEST OF THE POLICE, THE LOGS REMAINING IN C1 WERE PROVIDED.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: ON (B)(6) 2024, AT APPROXIMATELY 10:00 P.M., A "DISCONNECTION ON XXXXXX" OCCURRED. IT IS UNKNOWN WHETHER IT WAS ON THE PATIENT SIDE OR THE VENTILATOR SIDE. THE PATIENT SUBSEQUENTLY DIED. THE HOSPITAL DID NOT APPEAR TO DETERMINE THAT THERE WAS A PROBLEM WITH C1 AND THAT THE PATIENT DIED. AFTER THIS EVENT OCCURRED, THE POLICE ENTERED THE HOSPITAL TO CHECK THE OPERATION OF C1. LATER, ON JULY 1, THE HOSPITAL STAFF CONTACTED NK'S LOCAL STAFF TO RETRIEVE THE LOGS FROM C1. HOWEVER, THE LOG AT THAT TIME HAD BEEN LOST. ON JULY 5, AT THE REQUEST OF THE POLICE, THE LOGS REMAINING IN C1 WERE PROVIDED.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: ON (B)(6) 2024, AT APPROXIMATELY 10:00 P.M., A "DISCONNECTION ON XXXXXX" OCCURRED. IT IS UNKNOWN WHETHER IT WAS ON THE PATIENT SIDE OR THE VENTILATOR SIDE. THE PATIENT SUBSEQUENTLY DIED. THE HOSPITAL DID NOT APPEAR TO DETERMINE THAT THERE WAS A PROBLEM WITH C1 AND THAT THE PATIENT DIED. AFTER THIS EVENT OCCURRED, THE POLICE ENTERED THE HOSPITAL TO CHECK THE OPERATION OF C1. LATER, ON (B)(6), THE HOSPITAL STAFF CONTACTED (B)(6)'S LOCAL STAFF TO RETRIEVE THE LOGS FROM C1. HOWEVER, THE LOG AT THAT TIME HAD BEEN LOST. ON (B)(6) AT THE REQUEST OF THE POLICE, THE LOGS REMAINING IN C1 WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1498369 | HAMILTON MEDICAL AG | HAMILTON-C1 | CBK | HAMILTON MEDICAL AG | HAMILTON-C1 | 07630002800747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |