BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2251338 · Received August 12, 2011

    Report

    Report Number
    3008642652-2011-00424
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 10, 2011
    Report Date
    August 10, 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 ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (EXPOSED WIRES) HAS BEEN CONFIRMED. UPON EVAL THE ELECTRODE BELT CABLE WAS DAMAGED AT THE DISTRIBUTION NODE (DN). THE DN TO ECG "C AND D" CABLE WAS PULLED FROM THE STRAIN RELIEF AT THE DN. ADDITIONALLY, THE TRUNK CABLE CONNECTOR WAS CRACKED. THE CAUSE FOR THE DAMAGED CABLE AND TRUNK CABLE CONNECTOR CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM DAMAGED CABLE AND TRUNK CABLE CONNECTOR. THE PT REC'D A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE WIRES ON THE BACK OF HIS VEST WERE EXPOSED. THE PT REC'D A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR