BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1062685 · Received June 18, 2008

    Report

    Report Number
    1220908-2008-01222
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED. THE OTHER DEVICE THAT WAS USED DURING THE EVENT WAS REPORTED ON MEDWATCH NUMBER 1220908-2008-01219.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (GENDER UNK) THE DEVICE WOULD NOT DISCHARGE. THE CLINICIANS OBTAINED A SECOND DEVICE TO DEFIBRILLATE THE PT AND THAT DEVICE WAS UNABLE TO DISCHARGE. A THIRD DEVICE WAS OBTAINED AND THERAPY WAS CONTINUED. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO REPORTED MALFUNCTION.

    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 UNK