BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3982802 · Received June 13, 2014

    Report

    Report Number
    3008642652-2014-01806
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ZOLL LIFECOR CORP.
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK TE PAD MESSAGES, DAMAGED REAR TE PAD) WAS CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING. UPON EVAL, THE DISTRIBUTION NODE (DN) TO REAR TE CABLE WAS PULLED FROM THE STRAIN RELIEF AND THE HEAT SHRINK TUBING HAD COME OFF OF THE PULSE WIRES. THIS RESULTED IN A SHORT IN THE DN. THE CAUSE FOR THE CHECK TE PAD MESSAGES WAS THE SHORTED PULSE WIRE IN THE DISTRIBUTION NODE. THE CAUSE FOR THE SHORTED PULSE WIRE WAS THE PULLED CABLE. THE CAUSE FOR THE PULLED CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY A RESULT OF EXCESSIVE FORCE ON THE CABLE SECTION. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PT CONTACT ZOLL CUSTOMER SUPPORT TO REPORT THE PT'S BELT WAS DISPLAYING CHECK THERAPY (TE) PAD MESSAGES AND THAT THE REAR TE PAD WAS DAMAGED. PT WAS ISSUED A REPLACEMENT BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350776 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP. WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR