FDA Adverse Event
Summary report: N
HILL ROM AIR SHIELD
MDR report key: 1315638
·
Received February 13, 2009
Report
- Report Number
- 1315638
- Date Received
- February 13, 2009
- Date of Event
- February 7, 2009
- Report Date
- February 13, 2009
- Manufacturer
- DRAEGER MEDICAL
- Product Code
- FMZ
- Report Source
- User Facility report
- Reporter Location
- OH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
AN 11 DAY OLD BABY, BORN AT 31 WEEKS 5 DAYS, WAS PLACED IN THE ISOLETTE. A NURSE ENTERED THE ROOM TO FIND THE BABY ON THE FLOOR AND THE LEFT PORT HOLE AT THE HEAD OF THE ISOLETTE WAS OPEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HILL ROM AIR SHIELD | INCUBATOR, INFANT | FMZ | DRAEGER MEDICAL | C2HS-1 SERIES 2 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 DA |