BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3717508 · Received February 19, 2014

    Report

    Report Number
    3008642652-2014-00564
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 24, 2014
    Report Date
    February 18, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON EVAL, THE CABLE CONNECTING THE REAR THERAPY ELECTRODES (TE) AND THE DISTRIBUTION NODE (DN)WAS PULLED FROM THE STRAIN RELIEF AT THE DN. ADDITIONALLY THE CABLES CONNECTING ECG A AND B TO THE DN AND THE CABLE CONNECTING ECG C AND D TO THE DN WERE PULLED FROM THE STRAIN RELIEF AT THE DN. THE CAUSE OF THE PULSE LEAD HI-POT AND FALL-OFF FAILURES IS THE PULLED CABLES. THE ROOT CAUSE OF THIS DAMAGED CABLES AND INTERNAL WIRES CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLES. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLES AND WIRES. 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. DURING SERVICING, BELT SN (B)(4) FAILED THE PULSE LEAD HI-POT AND FALL-OFF TESTS. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104098 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA