FDA Adverse Event
Malfunction
Summary report: N
FISHER & PAYKEL HEALTHCARE
MDR report key: 25052247
·
Received April 30, 2026
Report
- Report Number
- 9611451-2026-01493
- Event Type
- Malfunction
- Date Received
- April 30, 2026
- Report Date
- May 1, 2026
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- FMT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(6). SECTION G4: THE IW990AEA WALL MOUNT INFANT WARMER IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K971441. SECTION D4: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING. FISHER & PAYKEL HEALTHCARE (F&P) IS IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
A HEALTHCARE FACILITY IN GERMANY REPORTED THAT THE IW990AGU WALL MOUNT INFANT WARMER IS DISPLAYING ERROR CODE 17. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 592371 | FISHER & PAYKEL HEALTHCARE | INFANT WARMER | FMT | FISHER & PAYKEL HEALTHCARE LTD | IW990AGU | 061214 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |