FDA Adverse Event
Injury
Summary report: N
HAMILTON-C1
MDR report key: 17794165
·
Received September 21, 2023
Report
- Report Number
- 0002937708-2023-00018
- Event Type
- Injury
- Date Received
- September 21, 2023
- Date of Event
- September 11, 2023
- Report Date
- September 21, 2023
- Manufacturer
- HAMILTON MEDCIAL AG
- Product Code
- CBK
- UDI-DI
- 07630002813426
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- NV, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
I JUST RECEIVED A CALL FROM ELIZABETH AT CENTENNIAL MARQUIS IN LAS VEGAS. VENT S/N 39512, THE SCREEN WENT BLACK WHILE IT WAS ON A PATIENT. THE PATIENT HAD SOME DECOMPENSATION, BUT IMPROVED WHEN THE VENTILATOR WAS SWITCHED OUT. VENT HAS BEEN PULLED OUT OF SERVICE. VENTILATION STOP WITHOUT TE OR TF LOGGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2036126 | HAMILTON-C1 | HAMILTON-C1 | CBK | HAMILTON MEDCIAL AG | HAMILTON-C1 | 07630002813426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| O |