BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1031410 · Received April 18, 2008

    Report

    Report Number
    9611451-2008-00141
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    January 11, 2008
    Report Date
    January 17, 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
    EI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACE THE CRACKED LEGS ON THE INFANT WARMER ELEVATOR BASE. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND RESULTS OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS, AS THE COMPLAINT DEVICE HAD NOT BEEN RETURNED. RESULTS: CRACKING LEGS OF THE COSYCAT INFANT WARMER, DUE TO EXCESSIVE WEIGHT LOADING, IS A KNOWN PROBLEM. TOTAL WEIGHT OF THE DEVICE, INCLUDING ACCESSORIES AND PT, 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, HAS BEEN COMPLETED IN THE USA, BUT IS STILL ON GOING IN OTHER COUNTRIES. THIS CORRECTIVE ACTION HAS BEEN NOTIFIED TO THE DISTRICT OFFICE.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED THAT A CRACK WAS FOUND ON THE LEG OF THE IW932AEK COSYCAT INFANT WARMER ELEVATOR BASE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSYCOT INFANT WARMER FMT FISHER & PAYKEL HEALTHCARE, LTD. IW932AEK

    Patients

    Seq Age Sex Outcome Treatment
    1