BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2843839 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02844
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 23, 2012
    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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE MONITOR FAILED A PULSE TEST. AN INTERMITTENT CONNECTION WAS FOUND ON QUAD MICROPOWER OP AMP U901. THE CAUSE FOR THE INTERMITTENT CONNECTION WAS A POOR SOLDER JOINTS AT PINS 3, 5, 12, AND 13 ON U901. THE ROOT CAUSE FOR THE POOR SOLDER JOINTS COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY A MFG ERROR. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE U901 COMPONENT. THE LAST PT TO USE THIS DEVICE DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. UPON SERVICING MONITOR SN (B)(4), THE MONITOR FAILED A PULSE TEST. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    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