BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1250036 · Received November 14, 2008

    Report

    Report Number
    3002158293-2008-00589
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    September 3, 2008
    Report Date
    November 14, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS REPRODUCED. THE CHARGER WAS DEFECTIVE WHEN EVALUATED. THE CONNECTOR AT THE BASE OF THE BATTERY CHARGER WOULD NOT STAY IN THE BATTERY CHARGER BASE. THE CONNECTOR WAS REPLACED. THE BATTERY CHARGER WAS RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE DEFECTIVE POWER BRICK IS UNK, BUT IS LIKELY MISMATING OF THE CONNECTORS. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BATTERY CHARGER. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    THE LIFECOR TERRITORY MGR (TM) OF A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE BATTERY CHARGER WAS NOT FUNCTIONING. HE STATED THAT IT WOULD NOT LIGHT UP AT ALL. THE TM TRIED MULTIPLE OUTLETS AND CHECKED ALL CONNECTIONS. THE TM REPLACED THE PT'S BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR