BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSYPKA PACE 203H

    MDR report key: 14631414 · Received June 8, 2022

    Report

    Report Number
    9681449-2022-00002
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    April 27, 2022
    Report Date
    June 7, 2022
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K020896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2022 FROM THE SWISS DISTRIBUTION PARTNER. DURING INITIAL VISUAL INSPECTION ONLY MAGINAL MECHANICAL DEFECT WAS FOUND WHICH WOULD NOT EXPLAIN THE REPORTED BEHAVIOR. THE PACEMAKER WORKED ACCORDING TO ITS SPECIFICATION. NO EVIDENCES COULD BE FOUND FOR ANY DEFECT. THE DEVICE WAS SUBJECTED TO A LONG-TERM TEST. AN ATTEMPT WAS MADE TO PROVOKE THE DESCRIBED DEFECT OVER A PERIOD OF 120 HOURS UNDER THERMAL CYCLING IN A CLIMA CHAMBER. THE PACEMAKER RAN WITHOUT INTERRUPTIONS AND SHOWED NO SIGNS OF A DEFECT. IT CANNOT BE EXCLUDED THAT A DEPLETED BATTERY CAUSED THE SHUTDOWN WHEN THE LOW BATTERY ALARM WAS NOT REQUOGNIZED BY THE USER. ALSO A HIDDEN DEFECT ON THE PRINTED CIRCUIT BOARDS COULD NOT BE EXCLUDED. FOR THIS REASON THE REPLACE OF THE ELECTRONIC BOARDS WERE SUGGESTED TO THE CUSTOMER AS PRECAUSION MEASURE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE INITIAL REPORTER: ACCORDING TO THE USER, THE DEVICE SWITCHES OFF WITHOUT ANY VISIBLE CAUSE OR MANIPULATION. IT WAS RECOGNIZED BY THE USER, WHO REPLACED THE DEVICE. THERE WERE NO SERIOUS CONSEQUENCES FOR THE PATIENT. THERE WERE NO FURTHER INFORMATION ABOUT THE PATIENT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12327 OSYPKA PACE 203H PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE OSYPKA MEDICAL GMBH PACE 203H

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown