BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSYPKA PACE 203H

    MDR report key: 11883997 · Received May 26, 2021

    Report

    Report Number
    9681449-2021-00001
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 21, 2021
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K020896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE DEVICE FOR EVALUATION ON 2021-05-10 FROM THE SWISS DISTRIBUTION PARTNER. DURING INITIAL VISUAL INSPECTION THE FOLLOWING SIGNS OF MECHANICAL DAMAGES HAVE BEEN FOUND: THE COVER OF THE CTRL OUT SOCKET WAS DAMAGED, HOUSING EDGES SHOW EVIDENCES OF MECHANICAL IMPACT AND BACK LABEL WAS DEFECT. AFTER OPENING OF THE HOUSING FOR INTERNAL INVESTIGATION, THE BATTERY CONTACT SPRINGS WERE FOUND PERMANENTLY BENT. ONE WAS 2.5 MM AND THE OTHER 3MM SHORTER THAN SPECIFIED. THE INVESTIGATOR WAS ABLE TO REPRODUCE THAT THE BATTERY LOST CONTACT TO THE TERMINAL SPRINGS AND THE "LOW BATTERY ALARM" WENT OFF. EXCEPT THIS THE PACEMAKER WORKED ACCORDING TO SPECIFICATION. THE INVESTIGATOR CONFIRMED THAT THE PERMANENTLY BENT BATTERY CONTACTS CAUSED THE DEFECT OF THE DEVICE. PROBABLY MECHANICAL IMPACTS SUCH AS DROP DOWN CASES OR ROUGH HANDLING CAUSED BENDING THE BATTERY SPRING TERMINALS PERMANENTLY. WHEN THE USER CHANGED TO A NEW BATTERY TYPE WHICH WAS ABOUT 1MM SHORTER THAN THE PRIOR USED MODEL, IT WAS DISCOVERED THAT THE BATTERY TERMINAL DO NOT PROVIDE CONTACT ANYMORE. THE USER WAS ABLE TO DISCOVER THE CONTACT PROBLEM DURING PREPARATION OF THE DEVICE BEFORE EVEN A PATIENT WAS CONNECTED. THE ACOUSTIC BATTERY ALARM AND A WARNING MESSAGE ON THE DISPLAY INDICATED THE BATTERY CONTACT PROBLEM. IN CASE OF DROP DOWN DURING OPERATIONS WHICH CAUSE A LOSS OF BATTERY CONTACT DUE TO BENT TERMINAL SPRINGS, THE OPERATOR WILL ALSO BE INFORMED BY THE ACOUSTIC LOW BATTERY ALARM AND CAN EXCHANGE THE PACEMAKER BY A BACK-UP DEVICE AS REQUIRED ACCORDING TO IFU. ALSO THE PACEMAKER HAS INCORPORATED AN INTERNAL ENERGY STORAGE CAPACITOR WHICH PROVIDE CONTINUOUSLY OPERATION DURING BATTERY CHANGE FOR AT LEAST 90 SEC.

    Description of Event or Problem · 1

    THE FOLLOWING HAVE BEEN REPORTED: DURING PREPARATION AFTER INSERTING A NEW BATTERY THE PACER WAS NOT IN CONTACT WITH THE BATTERY. ALTHOUGH THE BATTERY IS THE GIVEN TYPE (9 V BLOCK BATTERY 6LR61), IT IS ABOUT HALF A MILLIMETER TOO SHORT AND THE BATTERY FLAP DOES NOT PRESS ENOUGH AGAINST THE BATTERY CONTACT POINTS OF THE PACER. THE DEFECT IN THE DEVICE WAS RECOGNIZED BEFORE THE PATIENT WAS CONNECTED TO THE DEVICE. THIS HAD NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782558 OSYPKA PACE 203H EXTERNAL PULSE GENERATOR DTE OSYPKA MEDICAL GMBH PACE 203H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other