BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP NEO-THERM

    MDR report key: 279056 · Received May 22, 2000

    Report

    Report Number
    MW1018967
    Event Type
    Malfunction
    Date Received
    May 22, 2000
    Date of Event
    April 30, 2000
    Report Date
    May 22, 2000
    Manufacturer
    RESPIRATORY SUPPORT PRODUCTS, INC.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TEMP PROBE DOES NOT READ ACCURATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP NEO-THERM SKIN TEMPERATURE SENSOR FLL RESPIRATORY SUPPORT PRODUCTS, INC. * 1835

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other