BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1844512 · Received September 26, 2010

    Report

    Report Number
    9611451-2010-00573
    Event Type
    Malfunction
    Date Received
    September 26, 2010
    Report Date
    September 3, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED WARMER HEAD CASING WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: A 28 CENTIMETER CRACK WAS FOUND EXTENDING FROM THE BOTTOM EDGE TO THE FRONT END OF THE CASE. SOME SMALLER CRACKS WERE FOUND TO ORIGINATE FROM THE LARGE CRACK. THE HOSPITAL IDENTIFICATION STICKER WAS TORN AND DAMAGED AND THERE WERE SMALL CRACKS AND CRAZING ON THE POLYCARBONATE FILM WARMER HEAD LABEL. THE MIDDLE OF THE CASE HAD HAIRLINE CRACKS AND SOME CHIPPING. THERE WAS ALSO FLAKING OF THE CASE AND DELAMINATION OF THE PLASTIC ON ONE OF THE EDGES. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 050725. CONCLUSION: THE DAMAGE TO THE WARMER HEAD IS CONSISTENT WITH DAMAGED CAUSED BY 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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WARMER HEAD WAS RETURNED TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTER IN (B)(4).THE DAMAGED COMPONENTS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPONENTS AND COMPLETION OF OUR INVESTIGATION. DEVICE CURRENTLY EN ROUTE FOR EVALUATION.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN MISSOURI REPORTED THAT AN IW934 COSYCOT INFANT WARMER HEAD WAS CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN (B)(4) REPORTED THAT AN (B)(4) COSYCOT INFANT WARMER HEAD WAS CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD. IW934JEU 050725

    Patients

    Seq Age Sex Outcome Treatment
    1