BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL CONTROLLED INFANT WARMER

    MDR report key: 2802320 · Received October 23, 2012

    Report

    Report Number
    9611451-2012-00749
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    September 27, 2012
    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). METHOD: THE COMPLAINT IW990 INFANT WARMER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4) FOR REPAIR. THE COMPLAINT DEVICE WAS VISUALLY INSPECTED BY A TRAINED FPH TECHNICIAN AND PHOTOGRAPHS AND A SERVICE REPORT WERE PROVIDED TO US FOR OUR INVESTIGATION. RESULTS: VISUAL INSPECTION OF THE PHOTOGRAPHS REVEALED THAT THERE WAS CRAZING AND PEELING OF THE EMBOSSED SURFACES OF THE OPERATING MODE CONTROL BUTTONS. THE MANUAL CONTROL BUTTON TAB WAS BROKEN. THE HEAD UPPER CASE PHOTOGRAPH SHOWED PLASTIC CHIPPING AT THE BOTTOM EDGE OF THE HEAD. A CRACK LINE WAS NOTICEABLE ON THE DOME PORTION OF THE HEAD. CRAZING OF THE PAINT SURFACE WAS ALSO APPARENT IN THESE AREAS CONCLUSION: IT IS LIKELY THAT THE FLAKING AND CRACKING OF THE COMPLAINT WARMER HEAD AND THE DAMAGE TO THE FASCIA IS RELATED TO A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC AND ACRYLIC COMPONENTS OF THE INFANT WARMER. WHEN THE HEATER HEAD BEGINS TO WARM UP DURING USE, A CHEMICAL REACTION WITH THE INCOMPATIBLE CLEANING SOLUTION RESULTS IN GRADUAL CRACKING AND CRAZING OF THE HEATER HEAD. THIS WARMER IS AROUND 12 YEARS OLD. THE INFANT WARMER SERVICE MANUAL 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 OUR CONTINUOUS IMPROVEMENT INITIATIVES ON (B)(4) 2010, WE CHANGED THE MATERIAL USED IN THE MANUFACTURE OF THE HEAD HOUSING TO ONE THAT OFFERS GREATER RESISTANCE TO ENVIRONMENTAL STRESS CRACKING. WE ALSO REVISED OUR CLEANING INSTRUCTIONS TO RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES. THE COMPLAINT WARMER HEAD HOUSING KIT, CONTROL PANEL AND FASCIA WERE REPLACED AND THE UNIT WAS RETURNED TO SERVICE AT THE CUSTOMER'S FACILITY AFTER PERFORMING THE NECESSARY PERFORMANCE AND ELECTRICAL SAFETY TESTS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE FASCIA AND HEATER HEAD OF AN IW990 MANUAL CONTROLLED INFANT WARMER WAS DAMAGED AND NEEDED REPAIR. THIS WAS FOUND PRIOR TO PATIENT USE.

    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