BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARC INSTATEMP

    MDR report key: 7108022 · Received December 12, 2017

    Report

    Report Number
    3011197139-2017-00117
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    December 4, 2017
    Report Date
    December 12, 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

    THE CUSTOMER REPORTS THAT SHE FOUND THE DEVICE HAD RUPTURED AND HAD COME APART. CUSTOMER STATED THAT NO ONE WAS HURT. ARC REQUESTED THAT SHE RETURN THE DEVICE. A LAB ANALYSIS FOR THIS TYPE OF FAILURE WAS PERFORMED ON A 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
    889582 ARC INSTATEMP THERMOMETER FLL ARC DEVICES USA INC. CF1-0196

    Patients

    Seq Age Sex Outcome Treatment
    1