BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2990122 · Received September 12, 2012

    Report

    Report Number
    3008642652-2012-02397
    Event Type
    Malfunction
    Date Received
    September 12, 2012
    Date of Event
    August 22, 2012
    Report Date
    September 11, 2012
    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 OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON SERVICE INVESTIGATION THE TRUNK CABLE CONNECTOR PINS WERE BENT. THE ROOT CAUSE OF THE BENT PINS WAS UNABLE TO BE POSITIVELY IDENTIFIED, BUT WAS LIKELY EXCESSIVE FORCE WHEN CONNECTING THE ELECTRODE BELT TRUNK CABLE CONNECTOR TO THE MONITOR. NO ADVERSE EVENT RESULTED FROM THE BENT CONNECTOR PINS. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. UPON SERVICING ELECTRODE BELT SN (B)(4), THE TRUNK CABLE CONNECTOR PINS WERE BENT. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA