BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1040835 · Received May 9, 2008

    Report

    Report Number
    9611451-2008-00285
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Report Date
    March 14, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Removal / Correction Number
    Z-0485-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING DATES: 10/13/2005, 10/13/2005. REPLACED THE CRACKED BASES OF COSYCOT INFANT WARMERS. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND RESULTS OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS, AS THE COMPLAINT DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION. CRACKS ON THE ELEVATOR BASE OF THE COSYCOT INFANT WARMER, DUE TO EXCESSIVE WEIGHT LOADING, IS A KNOWN PROBLEM. TOTAL WEIGHT OF THE DEVICE, INCLUDING ACCESSORIES AND PATIENT, EXCEEDING 115 KG MAY, UNDER CERTAIN CIRCUMSTANCES, CAUSE CRACKS IN THE PLASTIC LEGS' BASE AND DAMAGE TO THE BASE ELECTRIC ELEVATOR MECHANISM. CONCLUSION: WE HAVE AN OPEN CAPA TO ADDRESS THIS ISSUE. THE CORRECTIVE ACTION INFORMING THE USERS OF THE MAXIMUM WEIGHT FOR THE COSYCOT INFANT WARMER AND TO INSPECT THE BASES OF THEIR COSYCOTS IS EXPECTED TO BE COMPLETED BY END OF 2008. THIS CORRECTIVE ACTION HAS BEEN NOTIFIED TO THE DISTRICT OFFICE.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT BASES OF THREE IW934JEU COSYCOT INFANT WARMERS HAD CRACKS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE, LTD. IW934JEU

    Patients

    Seq Age Sex Outcome Treatment
    1