BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROL COSYCOT INFANT WARMER

    MDR report key: 3630827 · Received February 17, 2014

    Report

    Report Number
    9611451-2014-00129
    Event Type
    Malfunction
    Date Received
    February 17, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 20, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 FOR EVALUATION. THEREFORE, OUR ANALYSIS IS BASED ON THE PHOTOGRAPH PROVIDED BY THE MEDICAL CENTRE, INVESTIGATION OF SIMILAR COMPLAINTS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE PHOTOGRAPH PROVIDED BY THE MEDICAL CENTRE REVEALED A LONGITUDINAL CRACK ON THE PLASTIC LEG NEAR THE BASE FRAME OF THE REPORTED IW934 COSYCOT INFANT WARMER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 070730. CONCLUSION: THE CRACK DAMAGE TO THE LEG OF THE IW934 COSYCOT INFANT WARMER WAS MOST LIKELY DUE TO OVERLOADING OF THE DEVICE AND EXCEEDING THE MAXIMUM WEIGHT CAPACITY OF 115 KGS. TO INCREASE AWARENESS AND TO REDUCE THE INCIDENCE OF CRACKED BASES, A WARNING IS PROVIDED IN THE FORM OF A "115 KG MAX WEIGHT" LABEL APPLIED TO THE COLUMN OF THE INFANT WARMER. THE MAXIMUM WEIGHT LIMIT IS SPECIFIED IN BOTH THE TECHNICAL MANUAL AND THE OPERATING MANUAL OF THE INFANT WARMER.

    Description of Event or Problem · 1

    A MEDICAL CENTRE IN (B)(6) REPORTED THAT THE PLASTIC LEGS OF AN IW934JEU BABY CONTROL COSYCOT INFANT WARMER WERE BROKEN. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100418 BABY CONTROL COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LIMITED IW934JEU 070730

    Patients

    Seq Age Sex Outcome Treatment
    1