BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1030336 · Received April 15, 2008

    Report

    Report Number
    9611451-2008-00157
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WILL BE CARRIED OUT ONCE WE RECEIVE THE COMPLAINT DEVICE. RESULTS: NO RESULTS TO DATE. CONCLUSION: NO CONCLUSION CAN BE PROVIDED AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED ONCE WE HAVE FURTHER INFORMATION.

    Description of Event or Problem · 1

    OUR DISTRIBUTOR REPORTED THAT THE BASE OF A COSYCOT INFANT WARMER WAS LEANING TO THE LEFT. 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. IW950

    Patients

    Seq Age Sex Outcome Treatment
    1