BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 2836069 · Received November 7, 2012

    Report

    Report Number
    1314800-2012-00048
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 6, 2012
    Manufacturer
    KAZ, INC.
    Product Code
    FLL
    PMA / PMN Number
    K983295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MOTHER OF A (B)(6) CHILD USED AN IRT 3020 INFRARED EAR THERMOMETER TO MONITOR THE TEMPERATURE OF THE CHILD AFTER HE GOT SICK BY BACTERIAL INFECTION. THE BABY WAS PREVIOUSLY TREATED BY ANTIBIOTICS. ONE WEEK AFTER TREATMENT, THE BABY SEEMED TO HAVE FEVER, BUT IRT 3020 GAVE A 37.4 DEGREE C RESULT. THE DAY AFTER THE BABY STILL SHOWED FEVER SYMPTOMS, BUT MEASUREMENT WITH IRT 3020 DISPLAYED A 37.5 DEGREE C. THIS TIME THE MOTHER REPEATED THE MEASURE WITH A RECTAL THERMOMETER, WHICH DISPLAYED 38.8 DEGREE C. THIS LED THE MOTHER TO GO TO THE HOSPITAL WITH THE CHILD, WHERE HE UNFORTUNATELY GOT INFECTED BY ANOTHER BACTERIUM. THE INFECTION CONTAMINATED THE WHOLE FAMILY, CAUSING THEM TO SAY AT HOSPITAL FOR 6 DAYS. THERE, TEMPERATURE MEASUREMENTS WERE PERFORMED ON THE CHILD USING IRT 3020 (GIVING 37.5 DEGREE C AND 37.7 DEGREE C AS RESULTS) AND WITH A RECTAL THERMOMETER (GIVING 39.4 DEGREE C AS A RESULT). THIS DATA WAS COMMUNICATED BY THE COMPLAINANT AND HAS NOT BEEN OTHERWISE VERIFIED. THE IRT 3020 THERMOMETER HAS BEEN SENT TO ONE OF THE MANUFACTURER'S SERVICE CENTERS WHERE IT HAS BEEN TESTED USING TEST FIXTURES (BLACK BODIES) FOR LABORATORY ACCURACY AND FOUND TO DELIVER ACCURATE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAUN THERMOMETER FLL KAZ, INC. IRT-3020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK