BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 2208656 · Received August 8, 2011

    Report

    Report Number
    1314800-2011-00034
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    June 16, 2011
    Report Date
    August 5, 2011
    Manufacturer
    KAZ, INC.
    Product Code
    FLL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    KAZ, USA RECEIVED NOTIFICATION FROM (B)(4) REGARDING REPORT OF A MALFUNCTION. THE TYMPANIC THERMOMETER IN QUESTION WAS CONSISTENTLY REGISTERING TEMPERATURES OF OVER 40 DEGREES CELSIUS AT A MEDICAL CENTER. THE THERMOMETER WAS PULLED FROM SERVICE AND SENT FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAUN THERMOMETER FLL KAZ, INC. PRO4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK