BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL WALL MOUNT INFANT WARMER

    MDR report key: 2766240 · Received October 1, 2012

    Report

    Report Number
    9611451-2012-00687
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Report Date
    September 3, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), SERIAL NUMBERS AND LOT DATE: (B)(4) 070130, (B)(4) - 070130, (B)(4) - 070130, (B)(4) - 070130, (B)(4) - 070130, (B)(4) - 070130. DEVICE MANUFACTURER DATE: 01/30/2007. METHOD: THE COMPLAINT WARMERS ARE NOT EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. OUR INVESTIGATION IS ACCORDINGLY BASED ON THE EVENT DESCRIPTION, PHOTOGRAPHS PROVIDED AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: INSPECTION OF THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER REVEALED CRACKS ON THE DOME PORTION OF THE HEATER HEAD, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: IT IS LIKELY THAT THE FLAKING AND CRACKING OF THE COMPLAINT WARMER HEAD 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 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, GLUTERALDEHYDE 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. A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE HAS SINCE BEEN IN CONTACT WITH THE CUSTOMER AND PROVIDED GUIDELINES ON CLEANING THE PRODUCTS AS PER THE TECHNICAL MANUAL.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEATER HEAD OF SIX BABY CONTROL WALL MOUNT INFANT WARMERS WERE CRACKED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABY CONTROL WALL MOUNT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW980 SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1