BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2212049 · Received July 8, 2011

    Report

    Report Number
    3008642652-2011-00175
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    April 29, 2011
    Report Date
    July 8, 2011
    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 CHARGER/MODEM ASSEMBLY (B)(4) HAS BEEN COMPLETED. THE ALLEGED PROBLEM (CHARGER NOT WORKING) HAS BEEN CONFIRMED. THE CAUSE FOR THE CHARGER NOT WORKING HAS BEEN ISOLATED TO A DEFECTIVE POWER SUPPLY UNIT. THE CAUSE OF THE POWER SUPPLY DEFECT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY POWER SUPPLY. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A PT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT ON BEHALF OF A (B)(6) FEMALE PT TO REPORT THAT THE PT'S BATTERY CHARGER/MODEM WAS NOT WORKING. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    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 65 YR