BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSYPKA PACE 203H

    MDR report key: 21124343 · Received January 10, 2025

    Report

    Report Number
    9681449-2025-00001
    Event Type
    Injury
    Date Received
    January 10, 2025
    Date of Event
    December 15, 2024
    Report Date
    January 10, 2025
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K020896
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PACEMAKER WITH S/N (B)(6) (INCL. BATTERY USED DURING THE INCIDENT) HAS BEEN RECEIVED AND TESTED BY THE UK DISTRIBUTION PARTNER AND REPRESENTATIVE ON 2024-12-24. AS THE RESULT THE PACEMAKER HAS WORKED AS EXPECTED WITH NO DEFECT. HOWEVER, THE BATTERY WHICH CAME WITH THE PACEMAKER HAS BEEN IDENTIFIED AS "ENERGIZER RECHARGE" NIMH RECHARGEABLE 9V BATTERY. THIS BATTERY TYPE IS NOT ALLOWED TO USE WITH EXTERNAL PACEMAKERS AND VERY LIKELY HAS CAUSED THE UNEXPECTED LOSS OF POWER. SINCE THE DEVICE HAS BEEN CONFIRMED FULLY FUNCTIONING THE MISUSE OF RECHARGEABLE BATTERIES CAN BE ASSUMED AS ROOT CAUSE OF THE INCIDENT. THE BATTERY MANAGEMENT SYSTEM OF THE PACEMAKER, ESPECIALLY AT LOW BATTERY CONDITIONS IS DESIGNED FOR PRIMARY BATTERIES ONLY SUCH AS ALKALINE 9V BATTERIES (IEC 60086: 6LR61 OR 6LF22). EXTERNAL PACEMAKERS MUST NOT BE POWERED BY RECHARGEABLE BATTERIES AS STATED IN THE IFU AND THE APPLICABLE PARTICULAR STANDARD IEC 60601-2-31. "THE POWER SOURCE IS RESTRICTED TO PRIMARY BATTERIES. ME EQUIPMENT POWERED BY RECHARGEABLE BATTERIES WOULD HAVE INTRINSICALLY ADDITIONAL SAFETY CONCERNS, SUCH AS: DIFFICULTY IN KNOWING LENGTH OF SERVICE TIME, STATE OF THE BATTERY (RECHARGED OR NOT), ETC."

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL: THE NURSE CHECKED THE PACING BOX AT THE START OF HER SHIFT AT 0830 AND MADE SURE THE BATTERY WAS FULL AND CONFIRMED THERE WERE 3 BARS ON THE CHARGE. AROUND 11 PM THE MONITOR STARTED ALARMING THE PATIENTS HEART RATE WAS DROPPING AND WENT INTO ASYSTOLE. THE NURSE NOTICED THAT THE EXTERNAL PACING BOX HAD TURNED OFF. THE NURSE IMMEDIATELY GOT A NEW BATTERY AND REPLACED IT. IT RESTARTED THE EXTERNAL PACING BOX AND THE PATIENT HAD OUTPUT AND A PACED RHYTHM. THE EXTERNAL PACING BOX DID NOT BLEEP OR ALERT TO INDICATE THERE WAS SOMETHING WRONG WITH THE BATTERY OR THE DEVICE. IT HAD TURNED OFF ABRUPTLY. WE HAVE THE PACING BOX AND THE BATTERY THAT WAS USED FOR THE DEVICE. THE INITIAL REPORTER HAS BEEN CONTACTED BY THE LOCAL DISTRIBUTION PARTNER AND REPRESENTATIVE DOT MEDICAL. THE DEVICE WITH SN (B)(6) ALONG WITH THE USED BATTERY WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169089 OSYPKA PACE 203H PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE OSYPKA MEDICAL GMBH PACE 203H

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Life Threatening