BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 5021275 · Received August 10, 2015

    Report

    Report Number
    1314800-2015-00063
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    June 1, 2015
    Report Date
    August 10, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    FLL
    PMA / PMN Number
    K103097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE THERMOMETER WAS SET TO CALIBRATION MODE FOR TESTING TEMPERATURES OF THE BLACKBODY. BLACK BODY SETTING DEGREES CELSIUS: 36.0, IRT-3020 DEGREES CELSIUS: 35.8; BLACK BODY SETTING DEGREES CELSIUS: 38.5, IRT-3020 DEGREES CELSIUS: 38.3; BLACK BODY SETTING DEGREES CELSIUS: 41.0, IRT-3020 DEGREES CELSIUS: 40.9. THE READINGS WERE WITHIN THE 0.2 DEGREES CELSIUS TOLERANCE FOR ACCURACY. THESE ARE PASSING RESULTS. THE ALLEGED MALFUNCTION COULD NOT BE DUPLICATED IN TESTING, AND THERE WERE NO DEFECTS FOUND IN THE RETURNED PRODUCT.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THEIR THERMOMETER WAS GIVING FALSE NEGATIVE READINGS ON THEIR CHILD. THE DEVICE ALLEGEDLY WAS READING 7 DEGREES LOWER THAN THE CHILD'S ACTUAL TEMPERATURE. THE CHILD WAS TREATED AT A HOSPITAL, WHERE IT WAS CONFIRMED THAT THEY HAD A FEVER. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING FINE NOW. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR LAB ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522608 BRAUN THEROMETER FLL KAZ USA, INC. IRT-3020 29913

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO Other| R