BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARC INSTATEMP

    MDR report key: 6940591 · Received October 11, 2017

    Report

    Report Number
    3011197139-2017-00109
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    September 14, 2017
    Report Date
    October 11, 2017
    Manufacturer
    ARC DEVICES USA INC.
    Product Code
    FLL
    PMA / PMN Number
    K152905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE THERMOMETER WAS FOUND IN THE MEDICINE CABINET (UNATTENDED) AND HAD EXPLODED. THE COVER CAME OFF THE UNIT. NO ONE WAS HURT. ARC REQUESTED THE CUSTOMER TO RETURN THE PRODUCT. A LAB ANALYSIS FOR THIS TYPE OF FAILURE WAS PERFORMED ON SIMILAR DEVICE. THE ANALYSIS OF THE BATTERIES INCLUDED AN OPTICAL MICROSCOPY, CT SCAN AND 2D X-RAY AND INDICATED THE FAILURE WAS DUE TO A SINGLE COMPONENT (BATTERY) MALFUNCTION. REPORT, ATTACHED. THE SUSPECT BATTERIES HAVE NOT BEEN IN USE SINCE (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720767 ARC INSTATEMP THERMOMETER, ELECTRONIC, CLINICAL FLL ARC DEVICES USA INC. CF1-0196

    Patients

    Seq Age Sex Outcome Treatment
    1