BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 3812956 · Received April 25, 2014

    Report

    Report Number
    3008642652-2014-01254
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 (SERVICE CODE 204) WAS CONFIRMED. UPON EVALUATION, THE ELECTRODE BELT'S TRUNK CABLE CONNECTOR WAS UNABLE TO SECURELY LATCH TO A MONITOR, CAUSING INTERMITTENT COMMUNICATION BETWEEN THE PT'S ELECTRODE BELT AND MONITOR AND THE REPORTED SERVICE CODE 204. THE ROOT CAUSE FOR THE DEFECTIVE TRUNK CABLE CONNECTOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE RECEIVED A SERVICE CODE THAT STATED THE BELT WAS USABLE. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251244 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR