BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PLUS

    MDR report key: 6328378 · Received February 14, 2017

    Report

    Report Number
    1220908-2017-00282
    Event Type
    Malfunction
    Date Received
    February 14, 2017
    Report Date
    January 26, 2017
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K011541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE REPORTED PROBLEM OF A "UNIT FAILED" IN RESCUE MODE WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE DEVICE ACTIVITY LOGS DID INDICATE THAT A "UNIT FAILED" MESSAGE OCCURRED IN NON-RESCUE MODE, WHICH INDICATES THAT THE DEVICE WOULD STILL FUNCTION IN RESCUE OR CLINICAL MODE. REPORTS OF THIS NATURE ARE TYPICALLY NOT CONSIDERED TO HAVE ANY CLINICAL IMPACT. 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 FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113375 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1