BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL MOBILE INFANT WARMER

    MDR report key: 2940432 · Received February 3, 2013

    Report

    Report Number
    9611451-2013-00073
    Event Type
    Malfunction
    Date Received
    February 3, 2013
    Date of Event
    November 29, 2012
    Report Date
    January 8, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE HEATING ELEMENT, UPPER HEAD CASE, LOWER HEAD CASE, AND UPPER HEAD HARNESS CONNECTOR OF THE AFFECTED IW910JEU BABY CONTROL MOBILE INFANT WARMER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE RETURNED COMPONENTS WERE VISUALLY INSPECTED. RESULTS: NO FAULT WAS FOUND WITH THE HEATING ELEMENT AND UPPER HEAD HARNESS CONNECTOR. CRAZING WAS EVIDENT ON THE FRONT END AND UPPER PART OF THE UPPER HEAD CASING. LONG LINES OF CRACKS WERE ALSO FOUND AT THE FRONT END OF THE WARMER HEAD. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 050620. CONCLUSION: IT IS LIKELY THAT THE CRACKING AND CRAZING OBSERVED ON THE WARMER HEAD ASSEMBLY ARE 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. 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." WE HAVE SINCE REVISED OUR CLEANING INSTRUCTIONS TO RECOMMEND SPECIFIC PROPRIETARY CLEANING WIPES. THE COMPLAINT WARMER HEAD ASSEMBLY WAS RETURNED TO THE HOSPITAL AFTER IT WAS REPAIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT HEATER HEAD CASING OF THE IW910JEU BABY CONTROL MOBILE INFANT WARMER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW910JEU BABY CONTROL MOBILE INFANT WARMER HAD A CRACKED UPPER HEAD CASE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN IW910JEU BABY CONTROL MOBILE INFANT WARMER HAD A CRACKED UPPER HEAD CASE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45854 BABY CONTROL MOBILE INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW910JEU

    Patients

    Seq Age Sex Outcome Treatment
    1