BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PLUS

    MDR report key: 6717087 · Received July 17, 2017

    Report

    Report Number
    1220908-2017-01628
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Report Date
    June 27, 2017
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946002152
    PMA / PMN Number
    K011541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE. REVIEW OF THE DEVICE ACTIVITY LOG INDICATED THAT THE ELECTRODE PADS WERE NOT ATTACHED TO THE DEVICE WHEN THE DEVICE WAS POWERED OFF IN NON-RESCUE MODE. THIS RESULTED IN THE DEVICE PROMPTING A "UNIT FAILED" ON THE NEXT POWER UP SESSION. OUR LABELING INDICATES THAT THE ELECTRODE PADS MUST BE CONNECTED AT ALL TIMES. REPORTS OF THIS NATURE ARE NOT CONSIDERED TO MEET OUR REQUIREMENTS FOR SUBMISSION OF A MEDWATCH REPORT. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    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
    497257 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PLUS NA 00847946002152

    Patients

    Seq Age Sex Outcome Treatment
    1