BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IWS 4400

    MDR report key: 744264 · Received June 6, 2005

    Report

    Report Number
    1121732-2005-00007
    Event Type
    Malfunction
    Date Received
    June 6, 2005
    Date of Event
    May 6, 2005
    Report Date
    June 3, 2005
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY NOTED PATIENT TEMPERATURE WAS HIGHER THAN EXPECTED. THERE WAS NO REPORTED PATIENT INJURY. OHMEDA MEDICAL'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IWS 4400 INFANT THERMOREGULATION FMT OHMEDA MEDICAL IWS 4400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO