BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3073105 · Received April 8, 2013

    Report

    Report Number
    3008642652-2013-00882
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 28, 2013
    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 (WON'T CONNECT TO MONITOR) WAS CONFIRMED. UPON INVESTIGATION THE TRUNK CABLE CONNECTOR PINS WERE BENT IN A SWIRL PATTERN, WHICH PREVENTED THE ELECTRODE BELT FROM CONNECTING TO A MONITOR. THE ROOT CAUSE FOR THE BENT PINS WAS LIKELY EXCESSIVE FORCE WHEN CONNECTING THE BELT TO A MONITOR. NO ADVERSE EVENT RESULTED FROM THE BENT PINS. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A ZOLL PATIENT SERVICE REPRESENTATIVE (PSR) CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS UNABLE TO CONNECT A (B)(6) MALE PATIENT'S ELECTRODE BELT TO A MONITOR. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142823 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR