BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4031082 · Received July 17, 2014

    Report

    Report Number
    3008642652-2014-02227
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 14, 2014
    Manufacturer
    ZOLL MANUFACTURING 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 INVESTIGATION THE BELT FAILED THE HIPOT TEST. THE CAUSE WAS CORROSION TO THE CRIMPS INSIDE ECG B. THE CORROSION CAUSED V2 TO OXIDIZE. THE CORROSION CAUSED THE FAILURE AT INCOMING TESTING. THE ROOT CAUSE OF THE CORROSION WAS UNABLE TO BE POSITIVELY IDENTIFIED, BUT WAS LIKELY LIQUID INGRESS OF AN UNK CONTAMINANT. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BELT. THE LAST PT TO USE THIS ELECTRODE 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 BELT FAILED INCOMING TESTING. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420679 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA