BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARC INSTATEMP

    MDR report key: 6940411 · Received October 11, 2017

    Report

    Report Number
    3011197139-2017-00108
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    September 11, 2017
    Report Date
    October 5, 2017
    Manufacturer
    ARC DEVICES USA INC.
    Product Code
    FLL
    PMA / PMN Number
    K152905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE THERMOMETER WAS FOUND EXPLODED IN THE BATHROOM CLOSET WHERE THE UNIT WAS SITTING UNATTENDED. 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 USED IN PRODUCTION SINCE 17 JULY 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721109 ARC INSTATEMP THERMOMETER, ELECTRONIC, CLINICAL FLL ARC DEVICES USA INC. CF1-0196

    Patients

    Seq Age Sex Outcome Treatment
    1