BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823423 · Received May 1, 2014

    Report

    Report Number
    3008642652-2014-01203
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION, THE CABLE CONNECTING THE DISTRIBUTION NODE WITH ECG ELECTRODES C AND D WAS PULLED FROM THE DISTRIBUTION NODE DAMAGING INTERNAL WIRES (BROWN LEAD 1-). THE ROOT CAUSE OF THE DAMAGED CABLE AND WIRES CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE AND WIRES. 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 PROBLEM. DURING SERVICING, BELT SN (B)(4) FAILED INCOMING HI-POT TESTING. THE LAST PATIENT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261584 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA