BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSYPKA PACE 203H

    MDR report key: 3209965 · Received June 26, 2013

    Report

    Report Number
    9681449-2013-00002
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 24, 2013
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K020896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT FORM FDA 3500A IS A CONTINUATION OF FORM FDA 3500 WHICH HAS SUBMITTED TO THE FDA VIA INTERNET ON (B)(4) 2013 BY OSYPKA MEDICAL (B)(4) (THE MFR). (B)(4).

    Description of Event or Problem · 1

    A BIOMED FROM HOSPITAL (B)(6), REPORTED THAT A SERIOUS MALFUNCTION OF AN OSYPKA PACE 203H DUAL CHAMBER EXTERNAL PACEMAKER (S/N (B)(4)) OCCURRED IN THE NIGHT OF (B)(6) 2013. WHILE THE PACEMAKER WAS CONNECTED TO A PATIENT, TWO NURSES HEARED AN ALARM BEEP INDICATING A DEVICE ERROR. THEY FOUND THAT WHILE THE DEVICE CONTROLS WERE LOCKED, THE STIMULATION RATE CHANGED WITHOUT USER INTERVENTION. THE CUSTOMER RETURNED THE DEVICE TO OUR DISTRIBUTOR IN (B)(4) WHO SENT THE DEVICE BACK TO THE MFR FOR EVALUATION (RECEIVED AT OSYPKA MEDICAL, (B)(4) ON (B)(4) 2013), WHICH WAS THE FIRST TIME OSYPKA MEDICAL BECAME AWARE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290568 OSYPKA PACE 203H EXTERNAL CARDIAC PACEMAKER DTE OSYPKA MEDICAL GMBH PACE 203H

    Patients

    Seq Age Sex Outcome Treatment
    1