BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3173440 · Received June 12, 2013

    Report

    Report Number
    3008642652-2013-01535
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DOES NOT RECOGNIZE BATTERY PACK) WAS CONFIRMED. UPON EVAL, THERE WAS CONTAMINATION ON THE BATTERY BOARD INSIDE THE CHARGER/MODEM. THE CAUSE OF THE INABILITY TO RECOGNIZE A BATTERY IS THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY LIQUID INGRESS OF AN UNK CONTAMINANT. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED CHARGER/ MODEM. THE PATIENT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THIS CHARGER/MODEM WILL NOT RECOGNIZE A BATTERY PACK. THE PATIENT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265921 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR