BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL MOBILE INFANT WARMER

    MDR report key: 2942066 · Received February 4, 2013

    Report

    Report Number
    9611451-2013-00072
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS RECENTLY BEEN RECEIVED AT OUR REGIONAL OFFICE IN THE USA AND EVALUATION IS CURRENTLY IN PROGRESS. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT WARMER HAS BEEN INSPECTED BY A FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER AT OUR REGIONAL OFFICE IN THE USA AND A VISUAL INSPECTION OF PHOTOGRAPHS PROVIDED HAS BEEN PERFORMED. RESULTS: THE VISUAL INSPECTION REVEALED CRACK LINES ON THE SURFACE OF THE DOME PORTION OF THE UPPER HEADCASE. A SMALL PORTION OF THE PLASTIC APPEARS TO HAVE SPLIT OFF FROM THE DOME AND CRAZING WAS NOTED AROUND THIS AREA. FLAKING OF THE PLASTIC BOTTOM EDGES AND A SMALL AREA APPEARS TO HAVE CHIPPED OFF. A LOT CHECK HAS REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE FLAKING AND CRACKING OF THE WARMER HEAD CASE IS CONSISTENT WITH DAMAGE CAUSED BY 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. 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 CONTINUOUS IMPROVEMENT, WE HAVE SINCE REVISED OUR CLEANING INSTRUCTIONS TO RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES. THE COMPLAINT HEATER HEAD WAS REPAIRED WITH A REPLACEMENT HEAD KIT AND WAS RETURNED TO THE CUSTOMER AFTER PERFORMING AN ELECTRICAL SAFETY AND PERFORMANCE CHECK.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE UPPER HEAD CASE FOR THE IW910JEU BABY CONTROL MOBILE INFANT WARMER IS "CRACKED". THIS WAS REPORTED AFTER PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE UPPER HEAD CASE FOR THE IW910JEU BABY CONTROL MOBILE INFANT WARMER IS "CRACKED". THIS WAS REPORTED AFTER PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46934 BABY CONTROL MOBILE INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW910JEU 090106

    Patients

    Seq Age Sex Outcome Treatment
    1