FDA Adverse Event
Injury
Summary report: N
GIRAFFE OMNIBED
MDR report key: 3546384
·
Received December 19, 2013
Report
- Report Number
- 1121732-2013-00003
- Event Type
- Injury
- Date Received
- December 19, 2013
- Date of Event
- October 9, 2013
- Report Date
- November 25, 2013
- Manufacturer
- OHMEDA MEDICAL
- Product Code
- FMZ
- PMA / PMN Number
- K101788
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. (B)(4) FILED BY THE HOSP, THE BRAND NAME WAS INDICATED AS GIRAFFE INFANT WARMER, HOWEVER, PER GE HEALTHCARE SITE VISIT, THE CORRECT DEVICE NAME WAS CONFIRMED TO BE A GIRAFFE OMNIBED.
Description of Event or Problem · 1
REF REPORT NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 665094 | GIRAFFE OMNIBED | NEONATAL INCUBATOR | FMZ | OHMEDA MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA | Other |