BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2160529 · Received July 1, 2011

    Report

    Report Number
    3008642652-2011-00130
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED MONITOR CASE) HAS BEEN CONFIRMED. UPON EVAL, THE MONITOR CASE WAS CRACKED, SEPARATING THE END CAP AND DISCONNECTING THE WHITE WIRES FROM THE AUXILIARY BOARD. THE CAUSE FOR THE DAMAGED CASE CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CASE AND DISCONNECTED WIRES. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS FRIEND "BUMPED [HIS] MONITOR AND THE CAP CAME OFF." THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR