HAMILTON-C6
Report
- Report Number
- 3001421318-2024-00404
- Event Type
- Malfunction
- Date Received
- February 20, 2024
- Date of Event
- February 11, 2024
- Report Date
- September 30, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002808590
- PMA / PMN Number
- K201658
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: FSN WAS INITIATED: Z-0267-2023 (B)(6) 2022: IN VERY RARE CASES, THE BACKLIGHT OF THE HAMILTON-C6 DISPLAY MAY FAIL. THIS IS ATTRIBUTABLE TO A RESET OF THE HMI CONTROLLER (HMI RESET) WHICH CAUSES THE DISPLAY TO FAIL FOR 2-3 SECONDS. THE DEVICE'S VENTILATION FUNCTION IS NOT AFFECTED BY THIS.
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: FSN WAS INITIATED: Z-0267-2023 (SEPTEMBER 22, 2022): IN VERY RARE CASES, THE BACKLIGHT OF THE HAMILTON-C6 DISPLAY MAY FAIL. THIS IS ATTRIBUTABLE TO A RESET OF THE HMI CONTROLLER (HMI RESET) WHICH CAUSES THE DISPLAY TO FAIL FOR 2-3 SECONDS. THE DEVICE'S VENTILATION FUNCTION IS NOT AFFECTED BY THIS. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:INTERACTION PANEL BLACKOUT FOR 2-3 SEC (HMI RESET).
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:INTERACTION PANEL BLACKOUT FOR 2-3 SEC (HMI RESET).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1067828 | HAMILTON-C6 | HAMILTON-C6 VENTILATOR | CBK | HAMILTON MEDICAL AG | 160021 | 07630002808590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |