MalfunctionFMT
SERVO-CONTROL WALL-MOUNT INFANT WARMER
Received Jun 5, 2026
Report 9611451-2026-01810 · MDR key 25406580
Device
Generic name
Infant Warmer
Manufacturer
Fisher & Paykel Healthcare LtdModel number
IW980AEUCatalog number
IW980AEU
Lot number
010918
Product problems
- Device Alarm System
- Defective Alarm
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). SECTION D4: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING. FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY 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 (B)(6) REPORTED THAT THE IW980AEU BABY CONTROL WALL MOUNT INFANT WARMER FAILED THE POWERFAIL AND CALIBRATION CHECK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.