BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL MOBILE INFANT WARMER

    MDR report key: 2921202 · Received January 17, 2013

    Report

    Report Number
    9611451-2013-00052
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 19, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO OUR REGIONAL OFFICE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE HEAD WARMER ASSEMBLY OF THE COMPLAINT IW910 MOBILE INFANT WARMER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) SERVICE CENTRE IN (B)(4), WHERE IT WAS VISUALLY EXAMINED BY A TRAINED FPH SERVICE ENGINEER. THE DAMAGED HEAD WARMER ASSEMBLY AND THE UPPER HEAD HARNESS WERE RETURNED TO FPH IN (B)(4) FOR FURTHER TESTING. RESULTS: VISUAL INSPECTION REVEALED CRAZING AND CRACK LINES ON THE DOME OF THE UPPER HEADCASE. FLAKING AND CHIPPING WAS ALSO NOTED ON THE BOTTOM EDGES OF THE UPPER HEADCASE. THE UPPER HEAD HARNESS WAS SLIGHTLY DISCOLOURED. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 070501. CONCLUSION: IT IS LIKELY THAT THE CRACKING AND CRAZING OBSERVED ON THE WARMER HEAD ASSEMBLY IS RELATED TO A KNOWN PROBLEM OF INCOMPATIBLE CLEANING SOLUTIONS REACTING WITH THE POLYCARBONATE PLASTIC AND ACRYLIC COMPONENTS OF THE INFANT WARMER. WHEN THE WARMER HEAD BEGINS TO WARM UP DURING USE, A CHEMICAL REACTION WITH THE INCOMPATIBLE CLEANING SOLUTION RESULTS IN GRADUAL CRACKING AND CRAZING OF THE WARMER HEAD. OUR CLEANING INSTRUCTIONS RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES. THE INFANT WARMER SERVICE MANUAL FOR THE AFFECTED UNIT 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." IN (B)(4) 2010, AS PART OF OUR ONGOING PRODUCT IMPROVEMENT INITIATIVES, THE MATERIAL OF THE UPPER AND LOWER WARMER HEAD CASES ON ALL INFANT WARMER MODELS WAS CHANGED TO A DIFFERENT MATERIAL THAT HAS GREATER RESISTANCE TO ENVIRONMENTAL STRESS CRACKING. THE UPPER AND LOWER HARNESSES ARE USED TO CONNECT THE HEAD UNIT TO THE CONTROL UNIT OF THE INFANT WARMER. THE DISCOLOURED HOUSING CONNECTOR WAS MOST LIKELY DUE TO ARCING THAT OCCURED BETWEEN TWO ELECTRICAL CONTACTS, LEADING TO CONTACT FAILURE. THE ARCING WAS PROBABLY CAUSED BY A POOR CONNECTION. ALL COMPONENTS ON THE HARNESS ASSEMBLY OF THE INFANT WARMER ARE ENCLOSED IN A SHEATH AND FIRE RATED BY UNDERWRITERS LABORATORIES (UL). SHOULD THE CONNECTORS COMPLETELY FAIL DURING THE OPERATION, AN AUDIBLE AND VISUAL ALARM WILL BE REGISTERED ON THE FRONT CONTROL PANEL OF THE INFANT WARMER, THEREBY ALLOWING THE HOSPITAL STAFF TIME TO ACT AND PROVIDE OTHER MEANS OF WARMING. THE DAMAGED COMPONENTS WERE REPLACED AND THE HEAD WARMER ASSEMBLY WAS RETURNED TO THE CUSTOMER AFTER PASSING THE ELECTRICAL SAFETY AND PERFORMANCE TESTS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE UPPER HEATER HEAD CASE ON AN IW910 MOBILE INFANT WARMER WAS CRACKED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE UPPER HEATER HEAD CASE ON AN IW910 MOBILE INFANT WARMER WAS CRACKED. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27028 BABY CONTROL MOBILE INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW910 070501

    Patients

    Seq Age Sex Outcome Treatment
    1