BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOTRONIC PACE 203

    MDR report key: 20012901 · Received August 21, 2024

    Report

    Report Number
    9681449-2024-00002
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 17, 2024
    Report Date
    July 17, 2024
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K020896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WITH SN (B)(6) INVOLVED HAS BEEN RETURNED BY THE BIOMEDICAL EQUIPMENT ENGINEERING OF THE DEBORAH HEART AND LUNG CENTER AND RECEIVED BY THE MANUFACTURER ON 2024-08-05. DURING INITIAL VISUAL INSPECTION MARGINAL MECHANICAL DEFECTS WAS FOUND WHICH WOULD NOT EXPLAIN THE REPORTED BEHAVIOR. THE PACEMAKER WAS FULLY TESTED AND WORKED ACCORDING TO ITS SPECIFICATION. NO EVIDENCES COULD BE FOUND FOR ANY DEFECT. THE DEVICE WAS SUBJECTED TO A LONG-TERM TEMPERATURE CYCLING TEST WITH MONITORED PACING ACTIVITIES. AN ATTEMPT WAS MADE TO PROVOKE THE DESCRIBED DEFECT OVER A PERIOD OF 140 HOURS. THE PACEMAKER RAN WITHOUT INTERRUPTIONS OR SHUTDOWN AND SHOWED NO SIGNS OF A DEFECT. THE INITIAL REPORTER HAS BEEN CONTACTED IN ORDER TO RECEIVE MORE DETAILS ABOUT THE CIRCUMSTANCES OR OTHER IMPORTANT DETAILS WHICH COULD EXPLAIN WHAT POSSIBLY HAS HAPPENED. UNTIL THE DAY OF THIS REPORT NO FURTHER INFORMATION HAVE BEEN GIVEN. THE DEVICE HISTORY RECORDS OF THIS SN HAS BEEN REVIEWED AND IT COULD BE CONFIRMED THAT THE DEVICE HAS PASSED ALL IN-PROCESS AND FINAL TESTS DURING PRODUCTION ON 2022-11-16. POSSIBLE REASONS FOR UNINTENDED SHUT OFF COULD BE: UNRECOGNIZED LOW BATTERY ALARM, SOME SOURCES OF RADIATED EMISSIONS MAY HAVE IMPACT THE PROPER FUNCTION OF THE PACEMAKER, SUCH AS ELECTROSURGICAL INSTRUMENTS WORKING WITH RADIO FREQUENCY, DEVICES FOR DIATHERMY THERAPY, MAGNETIC RESONANCE IMAGING (MRI), MEDICAL TELEMETRY SYSTEMS. AN HIDDEN COMPONENT FAILURE DEFECT ON THE PRINTED CIRCUIT BOARDS COULD ALSO NOT BE EXCLUDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTH PROFESSIONAL BIOMETICAL EQUIPMENT ENGINEERING 30-JUL-2024: THE EXTERNAL PACEMAKER PACE 203 WITH SN: (B)(6) INADVERTENTLY TURNED OFF WHILE IN USE. BIO MED ENGINEER COULD NOT REPRODUCE THE BEHAVIOR. THE INCIDENT DID NOT CAUSE ANY HARM FOR THE PATIENT ACCORDING TO THE HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045114 CARDIOTRONIC PACE 203 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE OSYPKA MEDICAL GMBH PACE 203

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other