BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERHEART G5 KIT,SEMI, US EN/LA ESP, CPRD

    MDR report key: 11002156 · Received December 14, 2020

    Report

    Report Number
    2112020-2020-01041
    Event Type
    Malfunction
    Date Received
    December 14, 2020
    Report Date
    November 23, 2020
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    UDI-DI
    00812394021307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE DATA LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING FULL FUNCTIONAL TESTING AND DWM SELF-TESTS WITHOUT DUPLICATING THE REPORT. INTERNAL INSPECTION OF THE DEVICE FOUND NO DISCREPANCIES. THE LOG WAS CLEARED. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE ELECTRODES USED WERE NOT RETURNED FOR EVALUATION. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468651 POWERHEART G5 KIT,SEMI, US EN/LA ESP, CPRD AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION G5S-80C NA 00812394021307

    Patients

    Seq Age Sex Outcome Treatment
    1