FDA Adverse Event
Malfunction
Summary report: N
MOBILE INFANT WARMER
MDR report key: 1172498
·
Received September 19, 2008
Report
- Report Number
- 9611451-2008-00545
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Report Date
- August 25, 2008
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- FMT
- PMA / PMN Number
- K970432
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION WILL BE CONDUCTED ONCE WE RECEIVE THE COMPLAINT DEVICE. A FOLLOW UP REPORT WILL BE PROVIDED.
Description of Event or Problem · 1
OUR CLINICAL PRODUCT SPECIALIST REPORTED THAT THE POWER FAILURE ALARM OF MOBILE INFANT WARMER WAS NOT FUNCTIONING. NO PATIENT 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 |