BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL CONTROLLED INFANT WARMER

    MDR report key: 2112185 · Received June 3, 2011

    Report

    Report Number
    9611451-2011-00326
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Report Date
    May 5, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT MANUFACTURER DATE: THIS PARTICULAR UNIT WAS MANUFACTURED IN 2000. METHOD: THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. IT HAS BEEN VISUALLY INSPECTED BY A FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER AT OUR REGIONAL OFFICE IN (B)(4). RESULTS: THE VISUAL INSPECTION REVEALED THE BOTTOM EDGE OF THE PLASTIC UPPERCASE AT THE LIGHT BOX END TO BE CHIPPED. DISCOLOURATION WAS ALSO NOTED ON THE TOP OF THE HEAD CASE. CRAZING WAS EVIDENT ON THE POLYCARBONATE FILM OF THE FASCIA, AND THE EMBOSSING ON THE BUTTON WAS BEGINNING TO PEEL. CRACK LINES WERE ALSO OBSERVED ON THE EDGES OF THE CONTROL KNOB. ONE PLASTIC SCREW BOSS OF THE CONTROL PANEL WAS OBSERVED TO BE BROKEN AT THE SCREW END. INSUFFICIENT INFORMATION WAS AVAILABLE IN ORDER FOR US TO PERFORM A LOT CHECK FOR THIS SERIAL NUMBER. CONCLUSION: IT IS LIKELY THAT THE CRACKING, CRAZING, CHIPPING AND DISCOLOURATION OF THE UPPER HEAD CASING IS RELATED TO A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC AND ACRYLIC COMPONENTS OF THE INFANT WARMER. ALONG WITH THE CONTINUAL USE OVER TIME, THIS IS ALSO LIKELY TO HAVE CAUSED THE PEELING AND CRAZING OF THE FRONT PANEL FASCIA. THE BROKEN CONTROL PANEL BOSS IS CAUSED BY THE DEFORMATION AND CRACKING OF THE SCREW BOSS DUE TO THE HIGH STRESS IN THE BOSS WHEN THE SCREW WAS INSERTED, RESULTING IN THE CRACK LINE OVER A LONG PERIOD OF TIME. IT SHOULD ALSO BE NOTED THAT THE COMPLAINT DEVICE IS MORE THAN 10 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 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. THE COMPLAINT DEVICE HAS SINCE BEEN REPAIRED AND RETURNED TO THE HOSPITAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE FRONT FASCIA AND WARMER HEAD OF AN IW990 MANUAL CONTROLLED INFANT WARMER WERE "DAMAGED." NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL CONTROLLED INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW990

    Patients

    Seq Age Sex Outcome Treatment
    1