BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1051749 · Received May 19, 2008

    Report

    Report Number
    9611451-2008-00316
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Report Date
    January 10, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND RESULTS OF PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS, AS THE COMPLAINT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. RESULTS: BROKEN BASE OF THE COSYCOT 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 THE OVERLOADING ISSUE OF THE COSYCOT INFANT WARMER. THE CORRECTIVE ACTION HAS BEEN ISSUED TO INFORM THE USERS OF THE MAXIMUM WEIGHT FOR THE COSYCOT INFANT WARMER AND TO INSPECT THE BASES OF THEIR COSYCOTS.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT THE BASE OF IW930JEU COSYCOT INFANT WARMER WAS BROKEN. 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. IW930JEU

    Patients

    Seq Age Sex Outcome Treatment
    1