BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECEST WCD 4000 SYSTEM

    MDR report key: 3221243 · Received June 26, 2013

    Report

    Report Number
    3008642652-2013-01547
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    December 11, 2012
    Report Date
    June 20, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P10030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT OR CHECK BELT MESSAGES, CHECK TE PAD MESSAGES) WAS CONFIRMED. UPON INVESTIGATION, DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE (TE) CABLE PULSE WIRE WAS BROKEN FROM THE SOLDER JOINT IN THE DN. THIS RESULTED IN AN OPEN PULSE WIRE CONNECTION IN THE DN. THE CAUSE OF THE BROKEN WIRE WAS A TRUNK CABLE THAT WAS PULLED FROM THE STRAIN RELIEF. THE ROOT CAUSE OF THE PULLED CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY 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) DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT AN ELECTRODE BELT WAS REPORTING CONSTANT CHECK THERAPY ELECTRODE PAD AND ADJUST BELT MESSAGES. THE DISTRIBUTOR WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289497 LIFECEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA