BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2946224 · Received January 4, 2013

    Report

    Report Number
    3008642652-2012-03370
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 8, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY - DEVICE EVAL OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. TE REPORTED PROBLEM (EQUIPMENT PROBLEM DURING PT SET-UP) WAS CONFIRMED. UPON INVESTIGATION, THE BATTERY CHARGER/MODEM BATTERY BOARD WAS CONTAMINATED. THE ROOT CAUSE OF THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY INGRESS OF AN UNK LIQUID. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED BATTERY CHARGER/MODEM. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    (B)(6) MALE PT'S NURSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S BATTERY CHARGER/MODEM WAS NOT PROPERLY CHARGING THE PT'S BATTERY PACKS. THE PT WAS PROVIDED WITH A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4901 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR