BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3061710 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00844
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 26, 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 EVALUATION THE ELECTRODE BELT FAILED A RESISTIVITY TEST. THE CAUSE FOR THE TEST FAILURE WAS ISOLATED TO AN INTERMITTENT SOLDER CONNECTION IN THE DISTRIBUTION NODE AT THE RED AND WHITE (PP+) WIRES. THE ROOT CAUSE FOR THE INTERMITTENT SOLDER JOINT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE LAST PATIENT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, BATTERY CHARGER/MODEM SN (B)(4) WAS UNABLE TO POWER UP. THE LAST PATIENT TO USE THIS BATTERY CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129721 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA