BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEO-THERM

    MDR report key: 237578 · Received August 22, 1999

    Report

    Report Number
    MW1017034
    Event Type
    Malfunction
    Date Received
    August 22, 1999
    Date of Event
    July 30, 1999
    Report Date
    August 22, 1999
    Manufacturer
    RESPIRATORY SUPPORT PRODUCTS, INC.
    Product Code
    HCS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE BROKE AND WOULD NOT PICK UP BABY'S SKIN TEMP. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEO-THERM SKIN TEMPERATURE SENSOR HCS RESPIRATORY SUPPORT PRODUCTS, INC. * 1576

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other