BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1220272 · Received October 23, 2008

    Report

    Report Number
    1220272
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 28, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    PATIENT NEEDED TO BE SHOCKED OUT OF FIBRILLATION. PADDLES WERE PLACED ON PATIENT'S CHEST. NO OTHER PART OF NURSE'S BODY WAS TOUCHING BED OR PATIENT. NURSE FELT SHOCK IN LEFT HAND AND SENSATION UP LEFT ARM. WAS LIGHT HEADED FOR FEW SECONDS ONLY. STAFF INJURY ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR, EXTERNAL MKJ ZOLL MEDICAL CORPORATION MSERIES *
    2 M-SERIES PADDLES, DEFIBRILLATION, EXTERNAL MKJ ZOLL MEDICAL CORPORATION 1001-0150-01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR CARDIAC DRUGS| CARDIAC DRUGS