BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1251524 · Received September 3, 2008

    Report

    Report Number
    1220908-2008-02018
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 25, 2008
    Report Date
    August 20, 2008
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT REC'D THE DEVICE FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION. PLEASE REFER TO THE ATTACHED USER MEDWATCH REPORT THAT ZOLL MEDICAL HAS REC'D.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A MALE PT DURING A CARDIOVERSION, 200J WERE SUCCESSFULLY DELIVERED HOWEVER, THE PT DID NOT CONVERT TO A NORMAL SINUS RHYTHM. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR