BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 1070637 · Received July 1, 2008

    Report

    Report Number
    1220908-2008-01393
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    June 8, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT, THE DEVICE CHARGED TO DELIVER TREATMENT, HOWEVER THE DEVICE FAILED TO DISCHARGE AND DISPLAYED AN UNKNOWN "BATTERY ERROR" MESSAGE. THE BATTERY WAS REPLACED, AND THE DEVICE WAS CHARGED A SECOND TIME AND THE DEVICE FAILED TO DISCHARGE AND DISPLAYED AN UNKNOWN "BATTERY ERROR" MESSAGE. THE DEVICE WAS CHARGED A THIRD TIME AND SUCCESSFULLY DELIVERED ENERGY TO THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. COMPLAINANT INDICATED THAT DURING SUBSEQUENT BIOMED TESTING, THE MALFUNCTION WAS NOT DUPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E SERIES DEFIBRILLATOR E SERIES MKJ ZOLL MEDICAL CORPORATION E SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK