BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL MOBILE INFANT WARMER

    MDR report key: 3299278 · Received August 20, 2013

    Report

    Report Number
    9611451-2013-00617
    Event Type
    Malfunction
    Date Received
    August 20, 2013
    Report Date
    August 12, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT WARMER HEAD ASSEMBLY WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INSPECTION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE EVENT INFORMATION AND PHOTOGRAPH PROVIDED BY THE MEDICAL CENTER, AND RESULTS OF PREVIOUS INVESTIGATION ON SIMILAR COMPLAINTS. RESULTS: THE PHOTOGRAPH PROVIDED SHOWED THAT THERE WERE CRACKED LINES ON THE WARMER HEAD DOME. CRAZING WAS ALSO VISIBLE AROUND THAT AREA. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 071029. 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. 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 REPLACED BY THE BIOMEDICAL TECHNICIAN OF THE MEDICAL CENTRE AT THEIR FACILITY.

    Description of Event or Problem · 1

    A MEDICAL CENTER IN SPRINGFIELD, OREGON REPORTED THAT THE WARMER HEAD ASSEMBLY OF AN IW910JEU BABY CONTROL MOBILE INFANT WARMER WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402783 BABY CONTROL MOBILE INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW910JEU 071029002103

    Patients

    Seq Age Sex Outcome Treatment
    1