BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3090064 · Received April 19, 2013

    Report

    Report Number
    3008642652-2013-01066
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATTERY PACK SN (B)(4) HAS NOT BEEN RETURNED FOR EVAL. THE REPORTED PROBLEM (BATTERY WON'T HOLD CHARGE) HAS NOT BEEN ABLE TO BE CONFIRMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF THE BATTERY PACK AND COMPLETION OF THE DEVICE EVAL. NO ADVERSE EVENT RESULTED AS A RESULT OF THE REPORTEDLY DEFECTIVE BATTERY PACK. THE PT WAS ISSUED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    THE NURSE OF AN (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S BATTERY PACK WOULD NOT CHARGE. THE PT WAS ISSUED A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169458 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR