BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 3983855 · Received June 20, 2014

    Report

    Report Number
    3008642652-2014-01910
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 19, 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 EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE HEAT SHRINK TUBING HAD COME OFF OF THE PULSE WIRE IN THE DISTRIBUTION NODE PCA. THE CAUSE FOR THE TEST FAILURES WAS THE SHORT IN THE DISTRIBUTION NODE. THE CAUSE FOR THE SHORT WAS THE DEFECTIVE HEAT SHRINK ON THE PULSE WIRE. THE ROOT CAUSE FOR THE DEFECTIVE HEAT SHRINK CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED WIRE.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA HAS DETECTED A REPORTABLE EVENT. UPON SERVICING, ELECTRODE BELT SN (B)(4) FAILED THE PULSE LEAD HI-POT TEST. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363516 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA