FDA Adverse Event
Injury
Summary report: N
HAMILTON C1
MDR report key: 10733299
·
Received October 23, 2020
Report
- Report Number
- MW5097443
- Event Type
- Injury
- Date Received
- October 23, 2020
- Date of Event
- September 7, 2020
- Report Date
- October 22, 2020
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
RT MANAGER REPORTED VENT ALARM VENTILATION CANCELED AND STOPPED WORKING. HE TURNED OFF UNIT AND TURNED BACK ON, WENT BACK TO NORMAL. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1195972 | HAMILTON C1 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | HAMILTON MEDICAL AG | C1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |