BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSYPKA CARDIOTRONIC

    MDR report key: 22838417 · Received August 19, 2025

    Report

    Report Number
    22838417
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    May 28, 2025
    Report Date
    July 9, 2025
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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
    2205188 OSYPKA CARDIOTRONIC PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE OSYPKA MEDICAL GMBH PACE 203

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male