BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 23711686 · Received December 3, 2025

    Report

    Report Number
    9611451-2025-01755
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Report Date
    January 9, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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. METHOD: THE COMPLAINT DEVICE IW990AEA WALL MOUNT INFANT WARMER WAS NOT RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P). OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULT: THE HEALTHCARE FACILITY REPORTED THAT THE IW990AEA WALL MOUNT INFANT WARMER WAS SHOWING ERROR CODE 17. CONCLUSION: THE REPORTED EVENT COULD HAVE CAUSED DUE TO EITHER HARNESS DEGRADATION OR THE ELEMENT BEING A OPEN CIRCUIT. THE USER MANUAL FOR THE IW990 INFANT WARMER STATES THE FOLLOWING: "ENSURE ALL WARMER PARTS AND ACCESSORIES ARE CHECKED BEFORE RETURNING THE DEVICE TO SERVICE." "CAUTION DO NOT CLEAN THE HIGHLIGHTED PLASTIC SURFACES WITH PROPRIETARY CLEANING PRODUCTS CONTAINING EITHER HYDROXIDES, HYDROCHLORITES, PEROXIDES, GLUTARALDEHYDE OR CLEANING PRODUCTS WITH A GREATER THAN 30% ALCOHOL BASE." "CAUTION THE CHEMICALS USED IN THESE PROPRIETARY CLEANING PRODUCTS MAY LEAD TO DISCOLOURATION, CRAZING AND EVENTUAL CRACKING OF THE HIGHLIGHTED PLASTIC SURFACES." THE DEVICE TECHNICAL/SERVICE MANUAL ALSO CONTAINS A CHECKLIST WHICH SPECIFIES THAT USERS PERFORM SAFETY, PERFORMANCE, AND FUNCTIONAL CHECKS AT LEAST ONCE A YEAR.

    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. 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 AUSTRALIA REPORTED THAT THE IW990AEA INFANT WARMER WALLMOUNT NONSRVO AEA IS SHOWING ERROR CODE 17. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN AUSTRALIA REPORTED THAT THE IW990AEA INFANT WARMER WALLMOUNT NONSRVO AEA IS SHOWING ERROR CODE 17. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979580 FISHER & PAYKEL HEALTHCARE INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE LTD IW990AEA 070620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown