BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL MOBILE INFANT WARMER

    MDR report key: 2133343 · Received June 20, 2011

    Report

    Report Number
    9611451-2011-00364
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Report Date
    May 25, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE'S (FPH'S) (B)(4) OFFICE, WHERE IT WAS EXAMINED BY A TRAINED FPH SERVICE TECHNICIAN. RESULTS: IT WAS FOUND THAT THE HEATER HEAD WAS PHYSICALLY DAMAGED. PHOTOGRAPHS WERE PROVIDED TO THE MANUFACTURER, SHOWING MULTIPLE CRACKS ON BOTH SIDES OF THE UPPER CASE. CRAZING WAS ALSO EVIDENT AROUND THIS AREA. THE LOWER MOULDED CASE ALSO SHOWED SOME CRACKS, POSSIBLY CAUSED BY IMPACT DAMAGE. A NEW HEATER HEAD HOUSING WAS FITTED TO THE UNIT. AND THE INFANT WARMER IS BACK IN SERVICE. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: THE MOBILE INFANT WARMER PROVIDES MOBILE WARMING WHEREVER NEEDED. IT CAN BE SUSCEPTIBLE TO IMPACT DAMAGE PARTICULARLY IF IT IS MOVED FROM ONE ROOM TO ANOTHER OR IF THE HEAD IS SWIVELED. IT IS ALSO POSSIBLE THAT THE CRACKING IS RELATED TO A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC AND ACRYLIC COMPONENTS OF THE INFANT WARMER. THE INFANT WARMER SERVICE MANUAL FOR THE AFFECTED UNITS FEATURES A DIAGRAM OF THE INFANT WARMER WHICH HIGHLIGHTS POLYCARBONATE AND ACRYLIC COMPONENTS AND STATES THE FOLLOWING: 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. AS PART OF CONTINUOUS IMPROVEMENT, WE HAVE SINCE REVISED OUR CLEANING INSTRUCTIONS TO RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES. REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEATER HEAD OF AN IW910 MOBILE INFANT WARMER WAS DETERIORATED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABY CONTROL MOBILE INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW910 081113001743

    Patients

    Seq Age Sex Outcome Treatment
    1