BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3061725 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00861
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 7, 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 MONITOR SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED THE MONITOR FAILED INCOMING PULSE TESTING WITH ASSOCIATED CODES 102 AND 203 - PULSE TEST FAULT. THE CAUSE FOR THE CODES 102 AND 203 IS A DAMAGED RESISTOR R30 (SM POWER RESISTOR) ON THE COMPUTER/ANALOG (CA) BOARD. ONE OF THE RESISTOR LEADS WAS DETACHED FROM THE CA BOARD. THE ROOT CAUSE OF THE DETACHED LEAD CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY MECHANICAL SHOCK FROM PHYSICAL IMPACT. NO ADVERSE EVENT RESULTED FROM THE BROKEN LEAD ON R30. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, MONITOR SN (B)(4) FAILED THE INCOMING PULSE TEST WITH ASSOCIATED SERVICE CODES 102 AND 203. THE LAST PT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130028 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA