BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2241530 · Received August 10, 2011

    Report

    Report Number
    3008642652-2011-00410
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 8, 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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED ELECTRODE BELT CONNECTOR) HAS BEEN CONFIRMED. UPON EVAL THE TRUNK CABLE CONNECTOR WAS BROKEN AND THE ELECTRODE BELT CABLE WAS DAMAGED AT THE DISTRIBUTION NODE (DN). THE DN TO REAR 2 WIRE THERAPY ELECTRODE PORTION OF THE CABLE WAS PULLED FROM THE STRAIN RELIEF AT THE DN. THE CAUSE FOR THE DAMAGED TRUNK CABLE CONNECTOR AND TRUNK CABLE CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CABLE AND CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS ELECTRODE BELT WAS DAMAGED AT THE CONNECTOR AND HIS MONITOR DISPLAYED SVC CODE 204. THE PT WAS PROVIDED WITH 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 50 YR