FDA Adverse Event
Malfunction
Summary report: N
COSYCOT INFANT WARMER
MDR report key: 2865038
·
Received September 30, 2010
Report
- Report Number
- 9611451-2010-00820
- Event Type
- Malfunction
- Date Received
- September 30, 2010
- Report Date
- September 2, 2010
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- FMT
- PMA / PMN Number
- K971695
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFO FROM THE HOSP IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT. WE WILL PROVIDE A F/U REPORT ONCE WE RECEIVE FURTHER INFO FROM THE HOSP AND HAVE COMPLETED OUR ANALYSIS.
Description of Event or Problem · 1
A HOSP IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE'S (FPH) SERVICE ENGINEER IN OUR US OFFICE THAT THE BASES OF 10 IW934JEU COSYCOT INFANT WARMERS WERE LEANING TOWARDS ONE SIDE. 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. | IW934JEU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |