HAMILTON-G5
Report
- Report Number
- 3001421318-2023-03793
- Event Type
- Malfunction
- Date Received
- November 9, 2023
- Date of Event
- October 24, 2023
- Report Date
- January 26, 2025
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800013
- PMA / PMN Number
- K193228
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 505
Narratives
INVESTIGATION IS ONGOING.
INVESTIGATION IS ONGOING. 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 AS REQUESTED.
INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION ADDED IN FOLLOW-UP #2 CER 103740. FIELD B4, G6, H2, H3, H6 AND H11 UPDATED. THE ISSUE WAS DISCOVERED DURING VENTILATION WITH NO PATIENT INVOLVED. THE EVENT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THE ROOT CAUSE OF THE EVENT WAS DEEMED TO BE AN ELECTRONIC DEFECT ON IP KEY AND LED BOARD MSP159234. AFTER REPLACING THE IP KEY AND LED BOARD MSP159234 THE DEVICE WAS FOUND TO BE FUNCTIONAL AND WAS RELEASED FOR USE. THE ISSUE IS CONSIDERED A REPORTABLE EVENT BECAUSE IT COULD POTENTIALLY IMPACT PATIENT SAFETY DURING VENTILATION SINCE THE ELECTRONIC DEFECT ON THE IP KEY AND LED BOARD MSP159234 COULD RESULT IN INADEQUATE VENTILATION SUPPORT.
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: SILENCE BUTTON IS NOT WORKING.
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: SILENCE BUTTON IS NOT WORKING.
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: SILENCE BUTTON IS NOT WORKING
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110715 | HAMILTON-G5 | HAMILTON-G5 VENTILATOR | CBK | HAMILTON MEDICAL AG | 159001 | 07630002800013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |