BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 3030661 · Received March 26, 2013

    Report

    Report Number
    3008642652-2013-00783
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A (B)(6) FEMALE PATIENT STUMBLED, FELL AND LANDED ON HER MONITOR, BREAKING HER HIP AND THE MONITOR. THE PATIENT WAS ADMITTED TO MEMPHIS BAPTIST EAST FOR SURGERY. THE ADVERSE EVENT WAS NOT A RESULT OF DEFECTIVE EQUIPMENT. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE DAUGHTER OF A (B)(6) FEMALE PATIENT NOTIFIED ZOLL CUSTOMER SUPPORT THAT THE PATIENT FELL ON HER MONITOR AND BROKE HER HIP. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123333 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR