BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSYCOT INFANT WARMER

    MDR report key: 1052716 · Received May 23, 2008

    Report

    Report Number
    9611451-2008-00301
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Report Date
    April 28, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    FMT
    PMA / PMN Number
    K971695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS CURRENTLY UNDERGOING INVESTIGATION. A FOLLOW UP REPORT WILL BE PROVIDED ONCE WE RECEIVE THE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    A HOSPITAL IN ANOTHER COUNTRY, REPORTED THAT THE CONTROL PCB BOARD OF IW952AEK COSYCOT INFANT WARMER WAS DEFECTIVE. THERE WAS AN ERRATIC CONTROL OF THE HEAT SETTING IN THE MANUAL MODE. 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. IW952AEK

    Patients

    Seq Age Sex Outcome Treatment
    1