BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2983309 · Received February 4, 2013

    Report

    Report Number
    3008642652-2013-00270
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 24, 2013
    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 (SERVICE CODE 204) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR'S ELECTRODE BELT RECEPTACLE WAS DAMAGED. PIN 1 OF J1001 WAS BENT PREVENTING THE ELECTRODE BELT FROM PROPERLY CONNECTING WITH THE MONITOR. THE BENT PIN CAUSED THE SERVICE CODE 204. THE ROOT CAUSE FOR THE BENT PIN COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE BENT PIN. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS RECEIVING A SERVICE CODE 204. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47390 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR