FDA Adverse Event
Death
Summary report: N
OHMEDA MEDICAL GIRAFFE OMNIBED
MDR report key: 339608
·
Received June 29, 2001
Report
- Report Number
- 1121732-2001-00004
- Event Type
- Death
- Date Received
- June 29, 2001
- Date of Event
- June 4, 2001
- Manufacturer
- OHMEDA MEDICAL
- Product Code
- FMT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT IN 2001 A PT HAD BEEN TREATED ON THE SUBJECT DEVICE FOR APPROXIMATELY 20 MINS WHEN AN ALARM WAS ACTIVATED AND IT WAS OBSERVED THAT THE PT'S SKIN WAS RED AND PEELING. THE UNIT WAS BEING USED IN MANUAL MODE WITH A HEAT OUTPUT OF 75%. THE PT'S SKIN WAS TREATED WITH GAUZE. THE DEVICE WAS THOROUGHLY EVALUATED BY A LOCAL SVC TECH AND FOUND TO FUNCTION PROPERLY. THE PT EXPIRED EIGHT DAYS LATER, REPORTEDLY DUE TO OTHER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29571 | OHMEDA MEDICAL GIRAFFE OMNIBED | INFANT INCUBATOR | FMT | OHMEDA MEDICAL | OMNIBED | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 DAY | Death |