BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G3, AHA 2005, US ENGLISH, NB2S

    MDR report key: 12565536 · Received October 1, 2021

    Report

    Report Number
    2112020-2021-00926
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Report Date
    September 10, 2021
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INADVERTENTLY SUBMITTED. IT WAS DETERMINED THAT THE 0X55 (HIGH IMPEDANCE) ERROR OBSERVED IN THE LOG WAS NOT PART OF THE CUSTOMER'S COMPLAINT AND OCCURRED DURING TESTING WHEN THE DEVICE WAS AT ZOLL FOR A PREVIOUS CUSTOMER COMPLAINT SUBMITTED ON MDR NUMBER 2112020-2021-00659. THIS CLAIM HAS BEEN CLOSED UNSUBSTATIATED. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE FAILED FOR HIGH IMPEDANCE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463544 G3, AHA 2005, US ENGLISH, NB2S AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9300E-501-NB2S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown