BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3636671 · Received December 19, 2013

    Report

    Report Number
    3008642652-2013-03589
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    November 14, 2013
    Report Date
    December 12, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 (ADJUST BELT OR CHECK BELT MESSAGES) WAS CONFIRMED. UPON INVESTIGATION THE TRUNK CABLE AND THE DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE (TE) CABLE WERE PULLED FROM THE STRAIN RELIEF. THE PULLED CABLES RESULTED IN A BROKEN PULSE WIRE SOLDER JOINT IN THE DN. THE CAUSE FOR THE ADJUSTED BELT OR CHECK BELT MESSAGES WAS THE DAMAGED PULSE WIRE SOLDER JOINT. THE ROOT CAUSE OF THE PULLED CABLES COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT ADJUST BELT OR CHECK BELT MESSAGES. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667655 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR