BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOTRONIC PACE 203

    MDR report key: 23153391 · Received September 26, 2025

    Report

    Report Number
    9681449-2025-00003
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    May 31, 2025
    Report Date
    September 19, 2025
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K020896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WITH SN (B)(6) INVOLVED IN THE INCIDENT WAS A LOANER DEVICE AND HAS BEEN RETURNED FROM (B)(6) HOSPITAL TO US MED-EQUIP (USME), THE OWNER OF THE PACEMAKER. INITIAL TESTING HAS BEEN PERFORMED AT USME BY A BIOMEDICAL TECHNICIAN. THE FOLLOWING FINDINGS HAS BEEN REPORTED TO OSYPKA MEDICAL ON 09/05/2025: "DURING THE PM TEST, THE UNIT POWERED ON BUT THEN ABRUPTLY SHUT OFF MID-TEST AND HAS NOT POWERED BACK ON SINCE. I ATTEMPTED TO USE MULTIPLE BATTERIES TO RULE OUT A POWER SOURCE ISSUE, BUT THE UNIT STILL FAILED TO POWER ON." THE DEVICE HAS BEEN SHIPPED TO THE MANUFACTURER IN GERMANY. OSYPKA MEDICAL RECEIVED THE UNIT ON 09/12/2025 AN INITIAL VISUAL INSPECTION HAS BEEN DONE. THE DEVICE SHOWED SIGNS OF SIGNIFICANT MECHANICAL DAMAGES ON THE HOUSING INCLUDING DAMAGES ON THE BATTERY COMPARTMENT DOOR. PICTURES ARE PROVIDED. THE DEVICE COULD NOT POWERED ON AT ALL. THE REASON FOR THE POWER ON PROBLEM WERE 2 DEFECT ELECTRONIC CHIPS ON THE POWER BOARD. THE MANUFACTURER IS VERY SURE THAT THESE CHIPS MUST HAVE BEEN INTACT DURING THE INCIDENCE AND COULD POSSIBLE BE DAMAGED DURING INITIAL TESTING AT USME BECAUSE IT WAS INITIALLY STILL WORKING THERE. THE IC DAMAGE COULD HAVE BEEN CAUSED DURING FUNCTIONAL TESTING DUE TO HIGHER VOLTAGE INPUT E.G. WHEN CONNECTING THE PACEMAKER BATTERY TERMINALS TO AN EXTERNAL POWER SUPPLY. BESIDE THIS CHIP DEFECT, WHICH COULD NOT BE PRESENT DURING THE INCIDENT, MAJOR MECHANICAL DAMAGES HAS BEEN FOUND WHICH PROBABLY CAUSED THE INTERMITTENT POWER PROBLEMS DURING THE INCIDENT. THE PACEMAKER IS POWERED BY A 9V BATTERY LOCATED IN A BATTERY COMPARTMENT AND SECURED BY A BATTERY COMPARTMENT DOOR. THIS COMPARTMENT DOOR COULD NOT BE CLOSED SECURELY DUE TO A BROKEN HINGE. ADDITIONALLY, THE BATTERY TERMINAL SPRINGS HAS BEEN BENT PERMANENTLY CAUSING ALSO INTERMITTENT BATTERY CONTACT PROBLEMS. IT CAN BE ASSUMED THAT THESE TWO DAMAGES CAUSED THE REPORTED INCIDENT. WITH THESE VISIBLE MECHANICAL DAMAGES THE USER SHOULD NOT HAVE USED THE PACEMAKER. IT SHOULD HAVE PUT OUT OF OPERATION AND PROVIDED FOR REPAIR. IT IS UNKNOWN WHEN THE LAST CHECK-UP HAS BEEN PERFORMED. IT CAN BE ASSUMED THAT THESE MECHANICAL DAMAGES HAS BEEN CAUSED BY DROP DOWN OR OTHER ROUGH HANDLING.

    Description of Event or Problem · 0

    PATIENT WITH TEMPORARY PACEMAKER POST HEART TRANSPLANT. PACEMAKER ORDERS ARE ATRIAL DEMAND INHIBITED, RATE 110. AS PER PRIMARY RN AT OR AROUND 10:30PM FOUND THE PACEMAKER BOX TO BE COMPLETELY OFF. THE RN CHANGED THE BATTERY HOWEVER THE BOX DID NOT TURN ON. AS PER THE RN ON [REDACTED] THE PREVIOUS SHIFT RN MENTIONED THAT THE BOX HAD TURNED OFF DURING THEIR SHIFT AND AFTER CHANGING BATTERY IT TOOK FEW MINUTES TO TURN BACK ON. CHECKED THE PATIENT AND TELE SHOWING SINUS RHYTHM WITH HR OF 90, INFORMED FIRST CALL PROVIDER, CONTACTED ICU CHARGE RN AND SWITCHED THE PACEMAKER BOX TO A NEW BOX. THE PACEMAKER BOX WILL BE SENT TO BIOMED AND HAS BEEN MARKED AS OUT OF ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279035 CARDIOTRONIC PACE 203 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE OSYPKA MEDICAL GMBH PACE 203

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Other