BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 23316745 · Received October 16, 2025

    Report

    Report Number
    9611451-2025-01069
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Report Date
    October 17, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION D4: UDI DETAILS ARE NOT AVAILABLE BASED ON THE TIME OF MANUFACTURING. SECTION G4: THE IW990AGU MANUAL-CONTROL 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 IW990AGU WALL MOUNT INFANT WARMER WAS RECEIVED AT OUR FISHER & PAYKEL HEALTHCARE (F&P) SERVICE CENTRE IN GERMANY WHERE IT WAS VISUALLY INSPECTED AND SERVICED BY A TRAINED F&P SERVICE TECHNICIAN. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION PROVIDED BY THE F&P SERVICE TECHNICIAN, INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE SUBJECT DEVICE CONFIRMED THAT THE WARMER HEAD WAS DAMAGED. CONCLUSION: WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED EVENT. THE USER MANUAL FOR THE IW990 INFANT WARMER STATES THE FOLLOWING: "CAUTION DO NOT CLEAN THE HIGHLIGHTED PLASTIC SURFACES WITH PROPRIETARY CLEANING PRODUCTS CONTAINING EITHER HYDROXIDES, HYDROCHLORIDES, 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.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN GERMANY REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE WARMER HEAD OF AN IW990AGU WALL MOUNT INFANT WARMER HAS CRACKS. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2694854 FISHER & PAYKEL HEALTHCARE INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE LTD IW990AGU 071119

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown