BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2881161 · Received November 16, 2012

    Report

    Report Number
    3008642652-2012-03037
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 14, 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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204, DAMAGED CONNECTOR PIN) HAS BEEN CONFIRMED. UPON INVESTIGATION, THERE WAS A BENT PIN IN THE ELECTRODE BELT'S TRUNK CABLE CONNECTOR, WHICH CAUSED THE SERVICE CODE 204. THE ROOT CAUSE FOR THE DAMAGED PIN COULD NOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR PIN. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT WAS RECEIVING A SERVICE CODE 204 AND A PIN ON THE PT'S ELECTRODE BELT CONNECTOR WAS DAMAGED. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    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 53 YR