BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2954301 · Received January 9, 2013

    Report

    Report Number
    3008642652-2013-00070
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 7, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 PINS IN THE ELECTRODE BELT¿S TRUNK CABLE CONNECTOR WERE BENT. THE ROOT CAUSE FOR THE BENT PINS WAS UNABLE TO BE POSITIVELY IDENTIFIED, BUT WAS LIKELY CAUSED BY EXCESSIVE FORCE AS THE BELT WAS MATED WITH THE MONITOR. NO ADVERSE EVENT OCCURRED DUE TO THE BENT PINS IN THE ELECTRODE BELT TRUNK CABLE CONNECTOR. THE LAST PATIENT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY PROBLEMS.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA HAS DETECTED A REPORTABLE EVENT. DURING SERVICING OF ELECTRODE BELT SN (B)(4), WHICH WAS RETURNED FOR NORMAL MAINTENANCE, BENT PINS WERE DISCOVERED IN THE TRUNK CABLE CONNECTOR. THE LAST PATIENT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11329 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA