BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1220877 · Received October 29, 2008

    Report

    Report Number
    3002158293-2008-00562
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 29, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATIONS OF BATTERY PACK AND BATTERY CHARGER HAVE 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. THE BATTERY PACK WAS FULL OF WATER. IT MAY HAVE BEEN DROPPED INTO SOME LIQUID. THE BATTERY PACK WAS SCRAPPED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CHARGER OR BATTERY PACK. THE PATIENT RECEIVED REPLACEMENT CHARGER AND BATTERY PACK.

    Description of Event or Problem · 1

    THE DAUGHTER OF A PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE BATTERY CHARGER IS NOT CHARGING THE BATTERY PACKS. SUPPORT SENT A PATIENT SERVICES REPRESENTATIVE (PSR) TO REPLACE THE BATTERY CHARGER. THE PSR REPORTED THAT ONE OF THE BATTERY PACKS WAS DISPLAYING THE "BATTERY PACK FAULT" LED ON THE NEW CHARGER. THIS BATTERY PACK WOULD ALSO NOT POWER THE MONITOR. SUPPORT HAD THE PSR REPLACE THIS BATTERY PACK AS WELL.

    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 55 YR