BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 3172800 · Received May 31, 2013

    Report

    Report Number
    3008642652-2013-01473
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DISCHARGE PROFILE FAULT FLAG) HAS BEEN CONFIRMED. UPON INVESTIGATION, DISCHARGE RESISTOR R46 WAS DETACHED FROM THE DEFIBRILLATOR BOARD. THE CAUSE OF THE DISCHARGE PROFILE FAULT FLAGS WAS THE DETACHED RESISTOR. THE ROOT CAUSE OF THE DETACHED RESISTOR WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DETACHED RESISTOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE DOWNLOAD DATE FOR A (B)(6) MALE PT REVEALED SEVERAL DISCHARGE PROFILE FAULTS. ZOLL CUSTOMER SUPPORT CONTACTED THE PT AND ISSUED HIM A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241578 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR