HAMILTON-C1
Report
- Report Number
- 3001421318-2024-00825
- Event Type
- Malfunction
- Date Received
- April 3, 2024
- Date of Event
- March 26, 2024
- Report Date
- October 22, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002800747
- PMA / PMN Number
- K181216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4).
HAMILTON MEDICAL AG CASE NUMBER IS: CER (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: WE HAVE CHECKED THE MAIN POWER SUPPLY AND POWER SUPPLY CABLE THEN WE CHECKED THE POWER SUPPLY BOARD OF THE VENTILATOR AND FOUND THAT THE OUTPUT VOLTAGE OF THE POWER SUPPLY BOARD IS 0. THEN WE REPLACED THE POWER SUPPLY BOARD AND DONE ALL THE TEST AND CALLIBRATIONS SUCCESSFULLY. NOW THE VENTILATOR IS WORKING SATISFACTORILY. NO HEALTH CONSEQUENCES OR IMPACT.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: WE HAVE CHECKED THE MAIN POWER SUPPLY AND POWER SUPPLY CABLE THEN WE CHECKED THE POWER SUPPLY BOARD OF THE VENTILATOR AND FOUND THAT THE OUTPUT VOLTAGE OF THE POWER SUPPLY BOARD IS 0. THEN WE REPLACED THE POWER SUPPLY BOARD AND DONE ALL THE TEST AND CALLIBRATIONS SUCCESSFULLY. NOW THE VENTILATOR IS WORKING SATISFACTORILY. NO HEALTH CONSEQUENCES OR IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1729239 | HAMILTON-C1 | HAMILTON-C1 | CBK | HAMILTON MEDICAL AG | 161001 | 07630002800747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |