FDA Adverse Event
Malfunction
Summary report: N
COSYCOT INFANT WARMER
MDR report key: 1781259
·
Received July 27, 2010
Report
- Report Number
- 9611451-2010-00456
- Event Type
- Malfunction
- Date Received
- July 27, 2010
- Report Date
- July 8, 2010
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- FMT
- PMA / PMN Number
- K971695
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE COMPONENTS OF THE COMPLAINT DEVICE IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 1
A HOSP IN (B)(6) REPORTED THAT THE HEATER HEAD OF AN IW934 COSYCOT INFANT WARMER IS DAMAGED. NO PT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COSYCOT INFANT WARMER | FMT | FISHER & PAYKEL HEALTHCARE, LTD. | IW934AFU | 060511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |