BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE INFANT WARMER

    MDR report key: 1907919 · Received November 25, 2010

    Report

    Report Number
    9611451-2010-00720
    Event Type
    Malfunction
    Date Received
    November 25, 2010
    Report Date
    November 2, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED WARMER HEAD HOUSING WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: THE SURFACE OF THE CASE WAS CRAZED AND THERE WERE CRACKS ON THE FRONT AND MIDDLE OF THE CASE. THE LOWER EDGE OF THE WARMER HEAD CASE WAS ALSO FOUND TO BE FLAKING OFF. DISCOLORATION WAS OBSERVED ON THE UPPER HOUSING HARNESS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 030109. CONCLUSION: THE CAUSE OF THE CRACKING AND FLAKING IS LIKELY TO BE A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC OF THE INFANT WARMER. THE INFANT WARMER UNIT IS APPROXIMATELY 7 YEARS OLD. THE INFANT WARMER SERVICE MANUAL FOR THE AFFECTED UNITS FEATURES A DIAGRAM OF THE INFANT WARMER WHICH HIGHLIGHTS POLYCARBONATE AND ACRYLIC COMPONENTS AND STATES: CAUTION DO NOT CLEAN THE HIGHLIGHTED PLASTIC SURFACES WITH PROPRIETARY CLEANING PRODUCTS CONTAINING EITHER HYDROXIDES, HYPOCHLORITES, 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. OUR CLEANING INSTRUCTIONS RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES THAT CAN BE USED TO CLEAN THE FRONT PANEL FASCIAS AND OTHER HIGHLIGHTED WARMER COMPONENTS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW910 INFANT WARMER HAD A CRACKED WARMER HEAD. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILE INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW910JEU 030109

    Patients

    Seq Age Sex Outcome Treatment
    1