BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEMQ

    MDR report key: 2920537 · Received December 7, 2012

    Report

    Report Number
    3008642652-2012-03227
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 4, 2012
    Report Date
    December 4, 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 (CODE 204, ADJUST BELT OR CHECK BELT MESSAGES) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR'S ELECTRODE BELT CONNECTOR WAS NOT FULLY SEATED IN J1001 ON THE CA BOARD. THIS PREVENTED THE MONITOR FROM PROPERLY COMMUNICATING WITH THE ELECTRODE BEL. THE ROOT CAUSE FOR THE IMPROPERLY SEATED CONNECTOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED MONITOR CONNECTOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WAS DISPLAYING A SERVICE CODE 204 AND ADJUST BELT OR CHECK BELT MESSAGES. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR