HAMILTON-G5
Report
- Report Number
- 3001421318-2025-00748
- Event Type
- Malfunction
- Date Received
- August 13, 2025
- Date of Event
- July 17, 2025
- Report Date
- February 2, 2026
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002802208
- PMA / PMN Number
- K193228
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). INVESTIGATION ONGOING.
HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1: INVESTIGATION OUTCOME. HAMILTON MEDICAL AG RECEIVED THE LOGFILES OF THE DEVICE FOR ANALYSIS. UPON REVIEW OF THE LOGFILES, AIR AND OXYGEN SUPPLY ALARMS WERE RECORDED. PLEASE SEE BELOW AN EXTRACT FROM THE LOGFILES. LINE 122: 2025-07-31 11:30:21 OXYGEN + AIR SUPPLIES FAILED SUPPLY 5017, LINE 163: 2025-07-29 13:11:36 OXYGEN + AIR SUPPLIES FAILED SUPPLY 5017, LINE 240: 2025-07-29 12:46:46 OXYGEN + AIR SUPPLIES FAILED SUPPLY 5017, LINE 318: 2025-06-30 11:25:54 OXYGEN + AIR SUPPLIES FAILED SUPPLY 5017, LINE 387: 2025-06-17 01:33:58 OXYGEN + AIR SUPPLIES FAILED SUPPLY 5017, THE CENTER DISK AND MIXER BLOCK ASSEMBLY WERE INITIALLY REPLACED; HOWEVER, THESE ACTIONS DID NOT RESOLVE THE REPORTED CONDITION. THE ISSUE WAS SUBSEQUENTLY ATTRIBUTED TO A DEFECTIVE SERVO MODULE, WHICH WAS REPLACED. SUBSEQUENT TESTING IDENTIFIED NO ADDITIONAL ISSUES, AND THE VENTILATOR PASSED ALL REQUIRED SERVICE CHECKS. THE DEVICE WAS RETURNED TO SERVICE.
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: THERE IS AIR LEAKING BETWEEN THE SERVO MODULE AND MIXER VALVE. NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299952 | HAMILTON-G5 | HAMILTON-G5 | CBK | HAMILTON MEDICAL AG | 159002 | 07630002802208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |