BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18170179 · Received November 20, 2023

    Report

    Report Number
    2112020-2023-01050
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    November 1, 2023
    Report Date
    November 2, 2023
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    UDI-DI
    00812394021307
    PMA / PMN Number
    P160033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE AND THREE SETS OF G5 ADULT ELECTRODE PADS (ONE WITH LOT# 230309-09 AND TWO WITH LOT# 230619-04) WERE RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE ELECTRODE PADS WERE RECIEVED OPENED AND STUCK TOGETHER. ALL THREE SETS OF PADS PASSED CONTINUITY TESTING AND WERE ABLE TO PROVIDE AN ECG SIGNAL AND SHOCK INTO AN ANALYZER. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE REPORT. AN INTERNAL INSPECTION OF THE DEVICE FOUND NO DISCREPANCIES. REVIEW OF THE DEVICE LOG FOUND NO EVIDENCE OF THE REPORT. THERE ARE NO ERRORS PRESENT BEFORE OR DURING THE PATIENT EVENT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND. AN ERROR 505 DOES NOT AFFECT THE DEVICE'S ABILITY TO BE USED CLINICALLY. THIS DOES NOT MEET OUR CRITERIA FOR REPORTABILITY.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT UPDATES INFORMATION BASED UPON YOUR REQUEST WHICH DIFFERS FROM THE INITIAL MEDWATCH REPORT FILED. PLEASE REFERENCE SECTIONS D1 UPDATED, D4 CATALOG # REMOVED, D4 PRIMARY UDI # UPDATED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DID NOT DETECT THE ATTACHED ELECTRODE PADS AND FAILED FOR HIGH IMPEDANCE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719493 POWERHEART G5 KIT,SEMI, US ENG/LA ESP, CPRD AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION G5S-80C NA 00812394021307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown