BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAUN

    MDR report key: 3802979 · Received May 5, 2014

    Report

    Report Number
    1314800-2014-00035
    Event Type
    Other
    Date Received
    May 5, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 1, 2014
    Manufacturer
    KAZ USA, INC.
    Product Code
    FLL
    PMA / PMN Number
    K983295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USING A WELCH ALLEN BLACK BODY THE IRT-3020 WAS RETESTED. THE BLACK BODY WAS SET TO 36.0 DEGREES CENTIGRADE AND THE IRT-3020 WAS SET TO CAL MODE. THE TEMPERATURE OF THE BLACK BODY WAS TAKEN AND THE READING WAS 55.7 DEGREES CENTIGRADE. THESE ARE FAILING RESULTS. THE THERMOMETER WILL BE SENT TO SUPPLIER FOR ROOT CAUSE ANALYSIS.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN AN INACCURATE READING. THE DEVICE WAS READING IN THE NORMAL RANGE DESPITE THEIR SON HAVING A FEVER. THE CHILD WAS GIVEN MOTRIN (ORALLY) AND WAS SEEN BY THEIR PHYSICIAN ON THE FOLLOWING DAY. THERE WERE NO FURTHER COMPLICATIONS AND THE PT IS DOING WELL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267853 BRAUN THERMOMETER FLL KAZ USA, INC. IRT-302 950

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other