BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSYPKA PACE 203H

    MDR report key: 10073873 · Received May 20, 2020

    Report

    Report Number
    9681449-2020-00005
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    April 24, 2020
    Report Date
    May 20, 2020
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K020896
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE DEVICE FOR EVALUATION ON 2020-05-11 FROM THE (B)(6). ACCORDING TO OUR REPAIR HISTORY RECORDS THE DEVICE HAS NOT BEEN RETURNED FOR SERVICE BEFORE. DURING INITIAL VISUAL INSPECTION TWO CRACKS ON THE UPPER PLASTIC HOUSING PART WERE FOUND. ONE OF THE CRACKS WAS ATTEMPTED TO REPAIR WITH SOME GLUE. THE INITIAL FUNCTIONAL TEST SHOWED NO PROBLEM. THE DEVICE WORKED WITHIN THE SPECIFICATION. A LONG TERM TEMPERATURE CYCLING TEST (48H) IN THE HEAT CHAMBER HAS ALSO PASSED WITHOUT FAILURES. AFTER OPENING OF THE HOUSING FOR INTERNAL INVESTIGATION, THE BATTERY CONTACT SPRINGS WERE FOUND PERMANENTLY BENT. THEY WERE ABOUT 2 MM SHORTER THAN SPECIFIED. SOME MECHANICAL TESTS WERE DONE BY SHAKING THE DEVICE IN HAND WHEN IT WAS OPERATING. THE INVESTIGATOR WAS ABLE TO REPRODUCE SEVERAL TIMES THE SITUATION THAT THE BATTERY LOST CONTACT TO THE TERMINAL SPRINGS AND THE "LOW BATTERY ALARM" WENT OFF. THE INVESTIGATOR BELIEVES THAT THE LOSS OF BATTERY CONTACT CAUSED THE INCIDENT. PROBABLY SEVERAL MECHANICAL IMPACTS CAUSED BY DROP DOWN OR ROUGH HANDLING DURING THE LAST 6 YEARS OF USE HAVE BENT THE BATTERY SPRING TERMINALS PERMANENTLY ADDITIONAL TO THE VISIBLE DAMAGES OF THE HOUSING AND CAUSED THE INTERMITTENT BATTERY CONTACT PROBLEM. ACCORDING TO IFU IT IS REQUIRED THAT THE PACEMAKER HAS TO BE INSPECTED FOR VISUAL DAMAGES BEFORE EACH USE AND AFTER ANY MALFUNCTION, INCIDENT, ROUGH HANDLING OR MECHANICAL SHOCK. IT SHOULD BE RETURNED FOR SERVICE AND FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE FOLLOWING HAVE BEEN REPORTED: PATIENT SITS IN THE MOBI CHAIR, PHYSIOTHERAPIST (B)(6) AS WELL AS HCH DR. (B)(6) PRESENT IN THE ROOM, NOT ON THE PATIENT EMPLOYED. DR. (B)(6) LEAVES THE ROOM, AT THE SAME TIME THE PATIENT REPORTS TO HEAR A "BEEP". WHEN THE PHYSIOTHERAPIST TURNS TO THE PATIENT, THE CENTRAL MONITOR ALREADY GIVES AN ASYSTOLE ALARM AND THE PATIENT PASSES OUT FOR A SHORT TIME. AT THE SAME TIME, EMPLOYEES CAME IN. WARD DOCTOR DR. (B)(6) DETERMINES THAT THE PACEMAKER IS TURNED OFF. THIS CAN BE SWITCHED ON IMMEDIATELY WITHOUT ANY PROBLEMS AND TAKES OVER ITS NORMAL OPERATION. THE BATTERY LEVEL IS ABOUT 75%, ALL SM CABLES ARE CORRECTLY ATTACHED. THE PATIENT ATTAINS WITHOUT ANY FURTHER MEASURES, EVEN WHEN LYING BACK IN BED WITHOUT ANY IMPAIRMENTS CONSCIOUSNESS BACK. NOTE: USED 9V BLOCK BATTERY VARTA INDUSTRIAL TYPE 6LR61.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539365 OSYPKA PACE 203H EXTERNAL PULSE GENERATOR DTE OSYPKA MEDICAL GMBH PACE 203H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other