BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1628457 · Received March 5, 2010

    Report

    Report Number
    9611451-2010-00113
    Event Type
    Malfunction
    Date Received
    March 5, 2010
    Date of Event
    February 4, 2010
    Report Date
    February 4, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RECEIVED BY FISHER & PAYKEL HEALTHCARE (B)(4), HOWEVER AN INVESTIGATION WAS CARRIED OUT BASED ON THE INFO PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF SIMILAR COMPLAINTS. RESULTS: ALTHOUGH NO COMPLAINT DEVICE NOR COMPONENTS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR TESTING, IT WAS REPORTED THAT THE CAPACITOR ON THE BOARD WAS REPLACED AND THE POWER FAIL ALARM NOW FUNCTIONS PROPERLY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 030704. CONCLUSION: THE POWER FAILURE COMPONENT OF THE INFANT WARMER CONTAINS A CAPACITOR WHICH STORES SUFFICIENT ELECTRICAL CHARGE TO POWER THE INFANT WARMER'S VISUAL AND AUDIBLE ALARM IN THE EVENT OF A FAILURE OF MAIN POWER. THE POWER FAIL ALARM CAPACITOR IS TESTED AS A PART OF THE WARMER'S ANNUAL MAINTENANCE CHECK AND REPLACED IF REQUIRED. THERE WERE NO PT CONSEQUENCES REPORTED IN RELATION TO THIS COMPLAINT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE POWER FAIL ALARM ON AN IW930 COSYCOT INFANT WARMER WAS NOT WORKING. THE CUSTOMER HAD OBSERVED THIS FAULT DURING A PREVENTATIVE MAINTENANCE CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE, LTD. IW930 030704

    Patients

    Seq Age Sex Outcome Treatment
    1