BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2415809 · Received December 8, 2011

    Report

    Report Number
    3008642652-2011-01230
    Event Type
    Malfunction
    Date Received
    December 8, 2011
    Date of Event
    July 15, 2011
    Report Date
    December 7, 2011
    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 WOULD NOT POWER ON. THE CAUSE OF THE FAILURE TO POWER ON WAS A DEFECTIVE U104 COMPONENT (PXA). THE CAUSE OF THE DEFECTIVE U104 COMPONENT CANNOT BE POSITIVELY IDENTIFIED BUT IS SUSPECTED TO BE A CRACKED CONDUCTOR OR SOLDER CONNECTION AT, OR NEAR, ONE ODF THE BGA CONNECTIONS ON THE BOTTOM OF THE U104 PROCESSOR. THE ROOT CAUSE OF THE INTERMITTENT CONNECTION IS SUSPECTED TO BE EXCESSIVE BENDING/FLEXING OF THE CA BOARD NEAR THE U104 PROCESSOR. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE U104 COMPONENT. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY PROBLEMS.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA HAS DETECTED A REPORTABLE EVENT. DURING SERVICING OF MONITOR SN (B)(4) WHICH WAS RETURNED FOR NORMAL MAINTENANCE, IT WAS DISCOVERED THAT THE MONITOR WOULD NOT POWER UP. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY PROBLEMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA