BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2912868 · Received November 30, 2012

    Report

    Report Number
    3008642652-2012-03153
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 27, 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 OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED CONNECTOR) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR'S ELECTRODE BELT CONNECTOR WAS BROKEN FREE FROM THE MONITOR CASE. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM THE MONITOR BEING DROPPED WHILE CONNECTED TO AN ELECTRODE BELT. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CALLED A ZOLL PT SERVICE REP (PSR) TO REPORT THAT THE ELECTRODE BELT CONNECTOR ON HIS MONITOR WAS BROKEN. ZOLL CUSTOMER SUPPORT CALLED THE PT AND ISSUED HIM 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 70 YR