FDA Adverse Event
Malfunction
Summary report: N
MOBILE INFANT WARMER
MDR report key: 1083872
·
Received July 28, 2008
Report
- Report Number
- 9611451-2008-00292
- Event Type
- Malfunction
- Date Received
- July 28, 2008
- Report Date
- July 1, 2008
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- FMT
- PMA / PMN Number
- K970432
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION WILL BE CARRIED OUT ONCE WE RECEIVE THE COMPLAINT DEVICE. A F/U REPORT WILL BE PROVIDED.
Description of Event or Problem · 1
A DISTRIBUTOR REPORTED THAT THE INFANT WARMER HEAD OF THE BABY CONTROLLED MOBILE INFANT WARMER HAD CRACKED. NO PT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOBILE INFANT WARMER | FMT | FISHER & PAYKEL HEALTHCARE, LTD. | IW910JEU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |