BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1203210 · Received October 9, 2008

    Report

    Report Number
    3002158293-2008-00531
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    September 22, 2008
    Report Date
    October 8, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS REPRODUCED. THE CAUSE OF THE CHARGER PROBLEM WAS AN UNKNOWN LIQUID IN THE BATTERY CHARGER. THE ROOT CAUSE OF THE DEFECTIVE CHARGER WAS PROBABLY LIQUID SPILLED INTO THE WELL OF THE BATTERY CHARGER. THE BATTERY CHARGER WAS SCRAPPED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CHARGER. THE PATIENT RECEIVED REPLACEMENT CHARGER.

    Description of Event or Problem · 1

    THE NURSE OF A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE BATTERY CHARGER WAS NOT CHARGING THE PATIENT'S BATTERY PACKS ALL THE WAY. SUPPORT HAD THE NURSE DOWNLOAD AND THE DOWNLOAD REVEALED A FAULT. SUPPORT SENT A PATIENT SERVICES REPRESENTATIVE (PSR) TO THE PATIENT TO REPLACE THE 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 UNK