BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3080848 · Received April 12, 2013

    Report

    Report Number
    3008642652-2013-00967
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 23, 2013
    Report Date
    April 4, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE RESISTANCE READING FROM THE DISTRIBUTION NODE (DN) WAS VARIABLE. THE RED AND WHITE (PP+) WIRES IN THE DN WERE FUND TO HAVE A COLD SOLDER JOINT. THE VARIABLE RESISTANCE READING WAS CAUSED BY THE COLD SOLDER JOINT. THE ROOT CAUSE OF THE COLD SOLDER JOINT WAS UNABLE TO BE POSITIVELY IDENTIFIED BUT IS LIKELY AN ASSEMBLY ERROR. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE LAST PATIENT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. UPON SERVICING ELECTRODE BELT SN (B)(4), THE RESISTANCE READING FROM THE DISTRIBUTION NODE (DN) WAS VARIABLE. THE LAST PATIENT TO USE THIS DEVICE DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158613 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA