BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2844845 · Received November 2, 2012

    Report

    Report Number
    3008642652-2012-02905
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    September 23, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER UP) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR WAS UNABLE TO POWER UP. THE CAUSE FOR THE POWER-UP FAILURE WAS ISOLATED TO AN INTERMITTENT BGA CONNECTION ON RAM CHIPS U100 AND U101 ON THE MONITOR C/A BOARD. THE ROOT CAUSE FOR THE INTERMITTENT BGA CONNECTIONS COULD NOT BE POSITIVELY IDENTIFIED, BUT THE FRACTURED BGA CONNECTIONS LIKELY RESULTED FROM EXCESSIVE STRESS ON THE MONITOR C/A BOARD. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(4) DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A PATIENT'S MONITOR WAS NOT POWERING UP. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    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