BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2946229 · Received January 4, 2013

    Report

    Report Number
    3008642652-2013-00003
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    November 18, 2012
    Report Date
    January 1, 2013
    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 (SERVICE CODE 204) HAS BEEN CONFIRMED. UPON INVESTIGATION MICROPROCESSOR U713 ON THE DISTRIBUTION NODE PCA BOARD HAD AN IMPROPER OUTPUT DUE TO A CORRUPTION OF THE PROCESSOR LOGIC. THIS CAUSED THE REPORTED SERVICE CODE 204. THE ROOT CAUSE FOR THE CORRUPTION OF THE U713 PROCESSOR LOGIC COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PT REC'D A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT WAS RECEIVING A SERVICE CODE 204. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5541 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR