BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSCOR

    MDR report key: 3574012 · Received December 23, 2013

    Report

    Report Number
    9681449-2013-00005
    Event Type
    Other
    Date Received
    December 23, 2013
    Date of Event
    October 6, 2013
    Report Date
    December 23, 2013
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K033130
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    F/U OF THE EVENT REPORTED BY OSCOR INC. ON (B)(6) 2013, NO. (B)(4), WHICH IS HEREWITH INCORPORATED BY REFERENCE. OSYPKA MEDICAL (B)(4), MFR OF THE MEDICAL DEVICE SUBJECT TO THE REPORT, WAS CONFIRMED ABOUT THIS WEEK ON (B)(6) 2013. EVENT DESCRIPTION: "THE OSCOR (PACE 101H) REQUIRES THE USER TO PLACE DIAL AT "F" FOR FIXED MODE INSTEAD OF A LABEL DEPICTING AN ASYNCHRONOUS MODE, WHICH IS THE INDUSTRY STANDARD TECHNOLOGY. FURTHERMORE, THERE WAS NO STANDARDIZED MARKINGS TYPICAL OF ASYNCHRONOUS MODES (A00, V00 AND D00) TO TELL PHYSICIANS THE OSCOR EXTERNAL PACEMAKER IS IN ASYNCHRONOUS MODE. THERE ARE MARKINGS FOR VVI THAT DEPICT SYNCHRONOUS MODE. AS A RESULT, THE PHYSICIANS WERE FORCED TO USE A DUAL-CHAMBER MEDTRONIC PACER. THERE SHOULD BE CLEAR STANDARDIZED MARKINGS DEPICTING FUNCTIONAL MODES ON EXTERNAL PACEMAKERS. THE NEW OSCOR IS VERY CONFUSING AND THERE ARE NO STANDARDIZED MARKINGS FOR STAFF TO FOLLOW. IN SHORT, THIS COULD BECOME A MORE SERIOUS PROBLEMS FOR SOMEBODY IN THE FUTURE WHO IS UNFAMILIAR WITH THE NON-STANDARD TECHNOLOGY USED BY OSCOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672985 OSCOR EXTERNAL CARDIAC PACEMAKER DTE OSYPKA MEDICAL GMBH PACE 101H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other