BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3003696 · Received February 12, 2013

    Report

    Report Number
    3008642652-2013-00377
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON EVAL THE TRUNK CABLE CONNECTOR PINS WERE BENT, WHICH PREVENTED THE ELECTRODE BELT FROM CONNECTING TO A MONITOR. THE ROOT CAUSE FOR THE BENT PINS COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM EXCESSIVE FORCE WHEN CONNECTING THE ELECTRODE BELT TO A MONITOR. NO ADVERSE EVENT RESULTED FROM THE BENT PINS. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    WHILE INVESTIGATING A (B)(6) FEMALE PT'S ELECTRODE BELT FOR AN UNRELATED ISSUE, A REPORTABLE PROBLEM WAS DISCOVERED. THE TRUCK CONNECTOR PINS ON ELECTRODE BELT SN (B)(4) WERE BENT. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61995 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR