FDA Adverse Event
Malfunction
Summary report: N
VEOLAR
MDR report key: 232691
·
Received July 20, 1999
Report
- Report Number
- 2937708-1999-00002
- Event Type
- Malfunction
- Date Received
- July 20, 1999
- Report Date
- July 13, 1999
- Manufacturer
- HAMILTON MEDICAL, INC.
- Product Code
- CBK
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
HAMILTON MEDICAL, INC., RECEIVED MED WATCH REPORT, NUMBER 1016385, FROM FDA, WHICH ALLEGED THAT A VEOLAR VENTILATOR, SERIAL NUMBER UNK FROM THE LACK OF INFO PROVIDED WHETHER THE VENTILATOR-IN-QUESTION FUNCTIONED IMPROPERLY OR CONTRIBUTED TO THE ALLEGED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VEOLAR | VENTILATOR | CBK | HAMILTON MEDICAL, INC. | VEOLAR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |