FDA Adverse Event
Summary report: N
INCUBATOR
MDR report key: 32480
·
Received March 22, 1996
Report
- Report Number
- 9611500-1996-00003
- Date Received
- March 22, 1996
- Date of Event
- March 14, 1996
- Report Date
- March 19, 1996
- Manufacturer
- DRAGERWERK AG
- Product Code
- FMZ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE INCUBATOR STOPPED RUNNING, GAVE ALARM AND THAT THE PT'S STATE OF HEALTH HAS BEEN DETERIORATED. PT'S WEIGHT 0.6 KGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INCUBATOR | INCUBATOR | FMZ | DRAGERWERK AG | 8000 IC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |