BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSYPKA

    MDR report key: 4121928 · Received August 1, 2014

    Report

    Report Number
    9681449-2014-00002
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 31, 2014
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K020896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(4): HOSPITAL SENT PACE 203H EXTERNAL PACEMAKER BACK TO MANUFACTURER FOR SERVICE WITH THE STATEMENT: 'DEVICE FAILED FUNCTIONAL & SAFETY TEST. DEVICE DOES NOT GENERATE STIMULATION PULSE.' UPON THE RECEIPT ON (B)(4) 2014 THE PACEMAKER WAS SUBJECT TO SHORT AND LONG TERM TESTING (72 H IN CLIMATE CHAMBER, 24 H MONITORING OF STIMULATION PULSES). THE DEVICE APPEARED TO BE FUNCTIONAL. THE ERROR COULD NOT BE REPRODUCED. ON (B)(6) 2014 WE CONTACTED THE BIOMEDICAL DEPARTMENT AND INQUIRED FOR MORE INFORMATION. APPARENTLY THE PACE 203H WAS USED ON A PATIENT WHO WAS ON AN EXTERNAL HEART-/LUNG- SUPPORT SYSTEM AND MONITORED. AN ALARM INDICATED A DYSFUNCTION OF PACE 203H SHOWING AN ERROR CODE WHICH WAS NOT REMEMBERED ANY MORE. PACE 203H WAS REPLACED BY ANOTHER EXTERNAL PACEMAKER. NO INJURY CAUSED BY OR RELATED TO THE DYSFUNCTION OF PACE 203H WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451712 OSYPKA EXTERNAL PACEMAKER DTE OSYPKA MEDICAL GMBH PACE 203H

    Patients

    Seq Age Sex Outcome Treatment
    1