BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2941681 · Received December 21, 2012

    Report

    Report Number
    3008642652-2012-03317
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 14, 2012
    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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESPONSE BUTTONS NOT WORKING) WAS CONFIRMED. UPON INVESTIGATION THE REAR RESPONSE BUTTON WAS NOT FUNCTIONAL. THE CAUSE FOR THE NON-FUNCTIONAL RESPONSE BUTTON WAS A DETACHED RESPONSE BUTTON CABLE. THE ROOT CAUSE FOR THE DETACHED CABLE COULD NOT BE POSITIVELY IDENTIFIED, BUT THE CABLE LIKELY DISCONNECTED AS A RESULT OF THE MONITOR IMPACTING A HARD SURFACE. NO ADVERSE EVENT RESULTED FROM THE DETACHED RESPONSE BUTTON CABLE. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR'S RESPONSE BUTTONS WERE NOT WORKING. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    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 57 YR