BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARC INSTATEMP

    MDR report key: 6994055 · Received November 1, 2017

    Report

    Report Number
    3011197139-2017-00111
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    October 6, 2017
    Report Date
    November 1, 2017
    Manufacturer
    ARC DEVICES USA INC
    Product Code
    FLL
    PMA / PMN Number
    K152905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE SHE HEARD A LOUD 'POP' FROM HER BATHROOM AREA AND REPORTS THAT THE UNIT BATTERIES EXPLODED. NO ONE WAS HURT. ARC REQUESTED THE CUSTOMER 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. THE SUSPECT BATTERIES HAVE NOT BEEN USED IN PRODUCTION UNITS SINCE JULY 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773912 ARC INSTATEMP THERMOMETER, ELECTRONIC, CLINICAL FLL ARC DEVICES USA INC CF1-0196

    Patients

    Seq Age Sex Outcome Treatment
    1