FDA Adverse Event
Injury
Summary report: N
GIRAFFE OMNIBED
MDR report key: 3553910
·
Received December 20, 2013
Report
- Report Number
- 1121732-2013-00004
- Event Type
- Injury
- Date Received
- December 20, 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 FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. (B)(4) FILED BY THE HOSPITAL, 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. THIS MDR WAS ORIGINALLY SUBMITTED ON (B)(6) 2013 WITH AN INCORRECT MANUFACTURER NUMBER. THE ORIGINAL SUBMISSION WAS UNDER MANUFACTURING REPORT NUMBER 1121732-2013-00003. A SUPPLEMENTAL MDR WAS SUBMITTED UNDER MFR REPORT #1121732-2013-00003 TO NOTE THE CORRECTION TO THE MANUFACTURING REPORT NUMBER.
Description of Event or Problem · 1
REFERENCE REPORT #: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 669077 | GIRAFFE OMNIBED | NEONATAL INCUBATOR | FMZ | OHMEDA MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA | Other |