BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PRO

    MDR report key: 2910515 · Received November 30, 2012

    Report

    Report Number
    1220908-2012-03217
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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 WHILE COMPLAINANT ALLEGED THAT WHILE ANALYZING THE HEART RHYTHM OF A (B)(6) MALE PATIENT, THE DEVICE ISSUED A ¿SHOCK ADVISED¿ PROMPT FOR A HEART RHYTHM THEY BELIEVE WAS NON-SHOCKABLE. 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
    1 AED PRO DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS AED PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR