BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3061726 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00866
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 27, 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 EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE BELT FAILED THE HI-POT TEST. UPON SERVICE INVESTIGATION THE ECG C AND D CABLE HEX CRIMP FERRULE CONNECTOR WAS NOT PROPERLY SEATED INTO THE J704 CONNECTOR. THE IMPROPER SEATING CAUSED INTERMITTENT FALL-OFF FAILURES. THE INTERMITTENT FAILURES LED TO THE FAILED HI-POT TEST. THE ROOT CAUSE FOR THE IMPROPERLY SEATED ECG C AND D CABLE CONNECTOR WAS UNABLE TO BE POSITIVELY DETERMINED, BUT MAY HAVE BEEN CAUSED BY PHYSICAL ABUSE PLACED ON THE TRUNK CABLE. NO ADVERSE EVENT RESULTED FROM THE IMPROPERLY SEATED CONNECTOR. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY PROBLEMS.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131113 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA