BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3073106 · Received April 8, 2013

    Report

    Report Number
    3008642652-2013-00901
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: BATTERY CHARGER/MODEM SN (B)(4) HAS NOT BEEN RETURNED FOR EVALUATION. THE REPORTED PROBLEM (BATTERY CHARGER NOT CHARGING BATTERY PACKS) HAS NOT BEEN ABLE TO BE CONFIRMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF THE BATTERY CHARGER/MODEM AND COMPLETION OF THE DEVICE EVALUATION. NO ADVERSE EVENT RESULTED AS A RESULT OF THE REPORTEDLY DEFECTIVE BATTERY CHARGER/MODEM. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S BATTERY CHARGER WAS NOT CHARGING THE PATIENT'S BATTERY PACK. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144566 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR