BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERHEART G5 KIT,SEMI,SLOVENE-INTL ENG

    MDR report key: 21478630 · Received February 27, 2025

    Report

    Report Number
    2112020-2025-00145
    Event Type
    Death
    Date Received
    February 27, 2025
    Report Date
    February 12, 2025
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE AND CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. PLEASE REFERENCE SECTION B1, B2, B5 AND H6 (MEDICAL DEVICE PROBLEM CODE & HEALTH EFFECT IMPACT CODE). THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS ATTRIBUTED TO THE USER NOT RESPONDING TO THE LOW BATTERY WARNINGS. A REVIEW OF THE DEVICE LOG INDICATED THE DEVICE BEGAN WARNING OF A LOW BATTERY ON (B)(6) 2024, BUT THERE'S NO EVIDENCE THAT THE USER ADDRESSED THE ISSUE UNTIL (B)(6) 2024. THE BATTERY, INSTALLED IN 2019, WAS NEARLY FIVE YEARS OLD, EXCEEDING ITS FOUR-YEAR STANDBY LIFE. THE DEVICE FUNCTIONED CORRECTLY, PROVIDING VISUAL AND AUDIBLE LOW BATTERY ALERTS AS DESIGNED. TESTING CONFIRMED IT WOULD HAVE BEEN CAPABLE OF DELIVERING SHOCKS IF A GOOD BATTERY HAD BEEN INSTALLED. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THE PATIENT SUBSEQUENTLY EXPIRED. THE CUSTOMER STATED THEY DO NOT BELIEVE THAT THE PATIENT'S LIFE WOULD HAVE BEEN SAVED HAD THE DEVICE WORKED AS INTENDED AS THE PATIENT WAS ELDERLY AND IN POOR HEALTH.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE FAILED TO DISCHARGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617726 POWERHEART G5 KIT,SEMI,SLOVENE-INTL ENG AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION G5S-36A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death