HAMILTON-C1
Report
- Report Number
- 3001421318-2024-00243
- Event Type
- Death
- Date Received
- January 30, 2024
- Date of Event
- January 10, 2024
- Report Date
- November 6, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800747
- PMA / PMN Number
- K181216
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- 505
Narratives
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. FOLLOW-UP 2 - INVESTIGATION RESULT: THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE LOG FILE ANALYSIS REVEALED THAT THE DEVICE WAS PUT INTO OPERATION ON 09.01.2024 AT 23:15. NO PRE-OPERATIONAL CHECK WAS CARRIED OUT. AFTER THE DEVICE WAS SWITCHED ON THE ALARM "MAXIMUM LEAK COMPENSATION" WAS CONTINUOUSLY DISPLAYED AND LOGGED IN THE SPECIFIED PERIOD OF THE EVENT. THE OFTEN LOGGED "DISCONNECTION ON PATIENT SIDE" ALARM COULD BE A CONSEQUENCE OF THE "MAXIMUM LEAK COMPENSATION". THE "LOSS OF PEEP" ALARMS INDICATE AN EXCESSIVE LEAKAGE. NO ADEQUANT OPERATOR RESPONSE TOOK PLACE REGARDING ABOVE THE MENTIONED (MORE THAN 60) ALARMS. INSTEAD, THE DEVICE WAS SIMPLY CONTINUED TO OPERATE. ACCORDING TO THE EVENT AND SERVICE LOGFILES THERE ARE NO ENTRIES REGARDING TECHNICAL FAULTS OR EVENTS, I.E. A MALFUNCTION OF THE DEVICE IS NOT APPARENT. NO ADEQUANT OPERATOR RESPONSE TOOK PLACE REGARDING MORE THAN 60 ALARMS. NO ACTION WAS TAKEN TO STOP SEVERAL ALARMS DURING THE OPERATING OF THE DEVICE. THEREFORE, BASED ON THE GIVEN INFORMATION, NO DEVICE FAULT COULD BE FOUND AND NO RELATION CAN BE FOUND TO THE PATIENT'S DEATH. A TREND REVIEW WAS PERFORMED OVER THE PERIOD OF 01.01.2021 UNTIL 01.10.2024 AND THERE ARE NO SIMILAR CASES REPORTED.
HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.
HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4).
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: BIOMED SAYS THAT HOSPITAL STAFF WAS GETTING LOTS OF DISCONNECTION ALARMS. HE SAYS THAT THE PATIENT HAS PASSED AWAY. SO FAR THIS HAS NOT BEEN CONFIRMED AND NO FURTHER INFORMATION HAS BEEN RECEIVED ABOUT THE INCIDENT AND THE CAUSE OF DEATH.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: BIOMED SAYS THAT HOSPITAL STAFF WAS GETTING LOTS OF DISCONNECTION ALARMS. HE SAYS THAT THE PATIENT HAS PASSED AWAY. SO FAR THIS HAS NOT BEEN CONFIRMED AND NO FURTHER INFORMATION HAS BEEN RECEIVED ABOUT THE INCIDENT AND THE CAUSE OF DEATH.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: BIOMED SAYS THAT HOSPITAL STAFF WAS GETTING LOTS OF DISCONNECTION ALARMS. HE SAYS THAT THE PATIENT HAS PASSED AWAY. SO FAR THIS HAS NOT BEEN CONFIRMED AND NO FURTHER INFORMATION HAS BEEN RECEVEIVED ABOUT THE INCIDENT AND THE CAUSE OF DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1032464 | HAMILTON-C1 | HAMILTON-C1 | CBK | HAMILTON MEDICAL AG | 161001 | 07630002800747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |