BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARC INSTATEMP

    MDR report key: 7664413 · Received July 5, 2018

    Report

    Report Number
    3011197139-2018-00014
    Event Type
    Malfunction
    Date Received
    July 5, 2018
    Date of Event
    June 10, 2018
    Report Date
    July 5, 2018
    Manufacturer
    ARC DEVICES USA INC
    Product Code
    FLL
    PMA / PMN Number
    K152905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THAT THE THERMOMETER WAS FOUND IN A RUPTURED STATE. NO ONE WAS HURT. ARC REQUESTED THE RETURN OF THE DEVICE. A LAB ANALYSIS FOR THIS TYPE OF FAILURE WAS PERFORMED ON A SIMILAR DEVICE. THE ANALYSIS INCLUDED AN OPTICAL MICROSCOPY, CT SCAN, 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 (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505358 ARC INSTATEMP THERMOMETER FLL ARC DEVICES USA INC CF!-0196

    Patients

    Seq Age Sex Outcome Treatment
    1