BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2881138 · Received November 16, 2012

    Report

    Report Number
    3008642652-2012-03029
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    September 13, 2012
    Report Date
    November 12, 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 EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK SN (B)(4) IS UNDERWAY. THE REPORTED PROBLEM (NOT WORKING IN MONITOR) WAS CONFIRMED. UPON INVESTIGATION, THE BATTERY WAS UNABLE TO RECHARGE OR POWER UP A TEST MONITOR. A ROOT CAUSE INVESTIGATION IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE ROOT CAUSE ANALYSIS. NO ADVERSE EVENT OCCURRED AS A RESULT OF THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT ONE OF HIS BATTERIES WAS READING CORRECTLY ON HIS MONITOR. THE PT WAS ISSUED A REPLACEMENT BATTERY PACK.

    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 50 YR