BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 1727832 · Received June 14, 2010

    Report

    Report Number
    1220908-2010-01584
    Event Type
    Death
    Date Received
    June 14, 2010
    Date of Event
    May 25, 2010
    Report Date
    June 4, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A (B) (6) MALE PT, THE DEVICE CHARGED UP AND ISSUED A SHOCK FOR A HEART RHYTHM THEY BELIEVE WAS NON-SHOCKABLE. THE COMPLAINANT STATED THAT THE PT WAS ALREADY ASYSTOLE WHEN PADS WERE APPLIED AND CPR WAS PERFORMED DURING THE ANALYSIS PHASE. COMPLAINANT INDICATED THAT THE POST EXAM DEATH OCCURRED 2-3 HOURS EARLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION MSERIES BI-PHASIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Death