BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1202449 · Received October 8, 2008

    Report

    Report Number
    9611451-2008-00593
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CRACKING OF INFANT WARMER HEAD IS POSSIBLY DUE TO THE USE OF INCOMPATIBLE CLEANING SOLUTIONS, CAUSING CHEMICAL REACTIONS TO THE POLYCARBONATE PLASTIC MATERIAL. AN INVESTIGATION WILL BE CONDUCTED, ONCE WE RECEIVE THE COMPLAINT DEVICE. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    A HOSPITAL IN IRELAND REPORTED THAT THEIR IW932AEK COSYCOT INFANT WARMER HEATER HEAD WAS CRACKING. 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