BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1813195 · Received August 19, 2010

    Report

    Report Number
    3002158293-2010-00862
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM HAS BEEN CONFIRMED. UPON RECEIPT, THE CABLE FROM ECG C TO THE DISTRIBUTION WAS DAMAGED. THE ROOT CAUSE OF THE DAMAGED CABLE CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE WIRES ON THE BELT ARE EXPOSED NEAR THE VIBRATION BOX. THE PT'S ELECTRODE BELT WAS REPLACED.

    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 48 YR