BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2843850 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02805
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ZOLL LIFECOR CORP
    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 32) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR DISPLAYED A CODE 32, WHICH PREVENTED THE MONITOR FROM FULLY BOOTING UP. THE CAUSE FOR THE CODE 32 WAS ISOLATED TO CORRUPT MONITOR SOFTWARE. THE ROOT CAUSE FOR THE CORRUPT SOFTWARE COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPT MONITOR SOFTWARE. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A ZOLL PT SERVICE REPRESENTATIVE (PSR) CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PT'S MONITOR WAS DISPLAYING CODE 32 (PT PARAMETERS CORRUPT). THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILALTOR MVK ZOLL LIFECOR CORP WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR