FISHER & PAYKEL HEALTHCARE
Received Apr 30, 2026
Report 9611451-2026-01493 · MDR key 25052247
Device
Generic name
Infant Warmer
Manufacturer
Fisher & Paykel Healthcare LtdModel number
IW990AGUCatalog number
IW990AGU
Lot number
001509
Product problems
- Electrical /Electronic Property Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). 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
A HEALTHCARE FACILITY IN GERMANY REPORTED THAT THE IW990AGU WALL MOUNT INFANT WARMER IS DISPLAYING ERROR CODE 17. THERE WAS NO REPORTED PATIENT INVOLVEMENT.