BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL MOBILE INFANT WARMER

    MDR report key: 3321087 · Received September 2, 2013

    Report

    Report Number
    9611451-2013-00658
    Event Type
    Malfunction
    Date Received
    September 2, 2013
    Report Date
    August 5, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) FROM THE HOSPITAL. OUR INVESTIGATION IS BASED ON OUR KNOWLEDGE OF THE PRODUCT AND PHOTOGRAPH PROVIDED BY THE HOSPITAL. RESULTS: THE PHOTOGRAPH REVEALED CRACKED LINES AT THE DOME PORTION OF THE COMPLAINT INFANT WARMER HEAD. DELAMINATION OF THE OUTER PLASTIC SHELL AND SURFACE CRAZING WERE VISIBLE. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 071101. CONCLUSION: IT IS LIKELY THAT THE PHYSICAL DAMAGE 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 CRAZING AND CRACKING OF THE HEATER HEAD. THE INFANT WARMER SERVICE MANUAL FOR THE AFFECTED UNIT FEATURES A DIAGRAM OF THE INFANT WARMER WHICH HIGHLIGHTS THE POLYCARBONATE & 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. A REPLACEMENT WARMER HEAD CASE WAS SENT TO THE HOSPITAL FOR THE BIOMEDICAL TECHNICIAN TO REPLACE THE COMPLAINT WARMER HEAD ASSEMBLY AT THEIR FACILITY, AS PER THE HOSPITAL'S REQUEST.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEAD CASE OF AN IW910 MOBILE INFANT WARMER WAS CRACKED NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433846 BABY CONTROL MOBILE INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW910 060202000160

    Patients

    Seq Age Sex Outcome Treatment
    1