HAMILTON MEDICAL AG
Report
- Report Number
- 3001421318-2023-00276
- Event Type
- Malfunction
- Date Received
- February 22, 2023
- Date of Event
- February 9, 2023
- Report Date
- April 11, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002808590
- PMA / PMN Number
- K201306
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- 505
Narratives
CONCLUSION: HAMILTON MEDICAL AG COMES TO THE FOLLOWING CONCLUSION: FIRST LOGFILE ANALYSIS: THE LOGFILE SHOWS THAT SINCE 2022-11-03 14:12:03 THE DEVICE STARTS UP WITH TE 231013 (QO2 FLOW SENSOR ERROR), TE 231008 (O2 VALVE OPEN) AND SELF TEST FAILED. AS A RESULT THE DEVICE CANNOT BE USED FOR VENTILATION. THE SELF TEST HAS FAILED AND VENTILATION WAS NOT POSSIBLE. THE TECHNICAL EVENTS INDICATE AN ISSUE WITH THE O2 SUPPLY (O2 SENSOR DEFECT AND O2 LEAK).
A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG ALMOST 3 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS NOT IN USE. THE ROOT CAUSE WAS DETERMINED TO BE AN O2 MIXER ASSEMBLY DEFECTIVE. IN CONSEQUENCE, THE PROBLEM SOLVED BY CHANGING THE O2 MIXER ASSEMBLY AND THE DEVICE WORKED PROPERLY AFTERWARDS. THERE WAS NO PATIENT OR USER HARM.
TO HAMILTON MEDICAL AG WAS THE FOLLOWING REPORTED: DURING TESTING, SOON AS HI PRESSURE O2 WAS APPLIED TO THE DEVICE TF231008 O2 VALVE LEAK WOULD APPEAR, REPLACEMENT OF THE O2 MIXER RESOLVED THE ISSUE, FROM: 160608: 00: 9152 TO MSP160608: 01: 20300. DURING PRE OP CHECKS WHILE USING THE TEST LUNG I COULD HEAR AN OSCILLATION OR SNORING SOUND COMING FROM THE DEVICE, WAS SOMEWHAT NOISY SO I REPLACED THE INSPIRATORY VALVE, FROM: 160230: 02: 18864 TO MSP160230: 02: 29749, ALSO REPLACED THE EXPIATORY VALVE FOR SAME REASON, FROM: 160240: 01: 18347. THE OSCILLATION IS FAR LESS NOTICEABLE NOW. AFTER REPLACEMENT OF THE EXPIATORY & INSPIRATORY VALVES THE DEVICE NOW ALARMED WITH PVENT MONITOR FAILURE FOR SOME REASON BUT REPLACEMENT OF THE MAIN BOARD RESOLVED THE ISSUE, FROM: 160362: 10: 11092 TO MSP160382: 10: 3023420. SERVICE SOFTWARE AND FUNCTION CHECKS ALL PASS. REPLACE O2 MIXER, REPLACE INSPIRATORY & EXPIATORY VALVES, REPLACED MAIN BOARD.
TO HAMILTON MEDICAL AG WAS THE FOLLOWING REPORTED: DURING TESTING, SOON AS HI PRESSURE O2 WAS APPLIED TO THE DEVICE TF231008 O2 VALVE LEAK WOULD APPEAR, REPLACEMENT OF THE O2 MIXER RESOLVED THE ISSUE, FROM: 160608: 00: 9152 TO MSP160608: 01: 20300. DURING PRE OP CHECKS WHILE USING THE TEST LUNG I COULD HEAR AN OSCILLATION OR SNORING SOUND COMING FROM THE DEVICE, WAS SOMEWHAT NOISY SO I REPLACED THE INSPIRATORY VALVE, FROM: 160230: 02: 18864 TO MSP160230: 02: 29749, ALSO REPLACED THE EXPIATORY VALVE FOR SAME REASON, FROM: 160240: 01: 18347. THE OSCILLATION IS FAR LESS NOTICEABLE NOW. AFTER REPLACEMENT OF THE EXPIATORY & INSPIRATORY VALVES THE DEVICE NOW ALARMED WITH PVENT MONITOR FAILURE FOR SOME REASON BUT REPLACEMENT OF THE MAIN BOARD RESOLVED THE ISSUE, FROM: 160362: 10: 11092 TO MSP160382: 10: 3023420. SERVICE SOFTWARE AND FUNCTION CHECKS ALL PASS. REPLACE O2 MIXER, REPLACE INSPIRATORY & EXPIATORY VALVES, REPLACED MAIN BOARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1572697 | HAMILTON MEDICAL AG | HAMILTON-C3 VENTILATOR | CBK | HAMILTON MEDICAL AG | HAMILTON-C3 | 07630002808590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |