BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 715304 · Received May 10, 2006

    Report

    Report Number
    1220908-2006-00911
    Event Type
    Malfunction
    Date Received
    May 10, 2006
    Date of Event
    March 20, 2006
    Report Date
    April 18, 2006
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO MONITOR THE HEART RHYTHM OF A PT (AGE & GENDER UNK) THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT DID NOT INDICATE THARE WAS NAY ADVERSE EFFECT TO THE PT DUE TO THE RPEORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other