FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C6
MDR report key: 18117784
·
Received November 13, 2023
Report
- Report Number
- 3001421318-2023-03827
- Event Type
- Malfunction
- Date Received
- November 13, 2023
- Date of Event
- October 28, 2023
- Report Date
- August 15, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002808590
- PMA / PMN Number
- K201658
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
NOTE: THIS REPORT WAS REPORTED LATE BECAUSE THE COMPLAINT HANDLING UNIT WAS RECEIVING IT LATE. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4).
Additional Manufacturer Narrative · 0
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 ISATTRIBUTABLE TO A RESET OF THE HMI CONTROLLER (HMI RESET) WHICH CAUSES THE DISPLAY TOFAIL FOR 2-3 SECONDS. THE DEVICE'S VENTILATION FUNCTION IS NOT AFFECTED BY THIS.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO (B)(6) MEDICAL AG: INTERACTION PANEL BLACKOUT FOR 2-3 SEC (HMI RESET).
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: INTERACTION PANEL BLACKOUT FOR 2-3 SEC (HMI RESET).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2238731 | HAMILTON-C6 | HAMILTON-C6 VENTILATOR | CBK | HAMILTON MEDICAL AG | 160021 | 07630002808590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |