BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 3110495 · Received May 14, 2013

    Report

    Report Number
    9611451-2013-00377
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 HEALTHCARE FACILITY, INVESTIGATION OF SIMILAR COMPLAINTS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE PHOTOGRAPH PROVIDED BY THE HEALTHCARE FACILITY REVEALED A LONGITUDINAL CRACK ON THE PLASTIC LEG UNDER THE COLUMN FOOTING OF THE REPORTED IW934 COSYCOT INFANT WARMER. CONCLUSION: THE CRACK DAMAGE TO THE LEG OF THE IW934 COSY COT INFANT WARMER WAS MOST LIKELY DUE TO OVERLOADING OF THE DEVICE AND EXCEEDING THE MAXIMUM WEIGHT CAPACITY OF (B)(4). TO INCREASE AWARENESS AND TO REDUCE THE INCIDENCE OF CRACKED BASES, A WARNING IS PROVIDED IN THE FORM OF A "(B)(4) 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. THE HEALTHCARE FACILITY WAS PROVIDED WITH A REPLACEMENT BASE WITH ALUMINIUM LEGS WITH A MAXIMUM CAPACITY OF 140 KGS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE BASE LEG OF AN IW934 COSYCOT INFANT WARMER WAS CRACKED. THEY FURTHER REPORTED THAT THE ELEVATOR FUNCTION AND MOTION ON THE REPORTED IW934 STILL WORK PROPERLY. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211986 COSYCOT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW934 080430

    Patients

    Seq Age Sex Outcome Treatment
    1