BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSYPKA PACE 203H

    MDR report key: 3195806 · Received June 24, 2013

    Report

    Report Number
    MW5030692
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PACE 203H DUAL EXTERNAL PACEMAKER (S/N (B)(4)) INDICATED SERIOUS ERROR WHILE BEING CONNECTED TO A PT. THE STIMULATION RATE CHANGED WITHOUT INPUT OF THE OPERATOR. VIGILANCE IN PROCESS. THE BODY OF THIS EXTERNAL PACEMAKER SHOWS SIGNS OF DAMAGE DUE TO DROPPING. THE APPARENTLY MALFUNCTIONING PACEMAKER WAS REPLACED BY A SIMILAR MODEL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284709 OSYPKA PACE 203H EXTERNAL PACEMAKER DTE OSYPKA MEDICAL GMBH PACE 203H

    Patients

    Seq Age Sex Outcome Treatment
    1