BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1220849 · Received October 29, 2008

    Report

    Report Number
    3002158293-2008-00561
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    September 19, 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 MFR DATE: BATTERY PACK . BATTERY CHARGER - 08/2007. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF BATTERY PACK AND BATTERY CHARGER HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS REPRODUCED. THE CAUSE OF THE CHARGER PROBLEM WAS AN UNK 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. 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 PT RECEIVED REPLACEMENT CHARGER AND BATTERY PACK.

    Description of Event or Problem · 1

    A FEMALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT WHEN ONE BATTERY PACK IS PLUGGED INTO THE BATTERY CHARGER THE GREEN LIGHT STAYS LIT AT THE SAME TIME AS THE RED BATTERY FAULT LIGHT BLINKS. SHE STATED THAT THE OTHER BATTERY PACK DOES NOT DO THIS. SUPPORT ASKED THE PT TO DOWNLOAD AND THE DOWNLOAD DID NOT REVEAL ANYTHING OUT OF THE ORDINARY. PT WAS CURRENTLY NOT AT HOME AND STATED SHE WOULD CALL WHEN SHE RETURNED HOME. PT CALLED TO REPORT THAT THE BATTERY PACK WOULD NOT START THE MONITOR AT ALL. THE OTHER BATTERY PACK STARTED THE MONITOR NORMALLY. SUPPORT SENT A PT SERVICES REPRESENTATIVE (PSR) TO THE PT TO REPLACE THE DEFECTIVE BATTERY PACK AND 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 36 YR