BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1250038 · Received November 14, 2008

    Report

    Report Number
    3002158293-2008-00591
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 18, 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 Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER (B) (4) HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS REPRODUCED. THE CAUSE OF THE CHARGER PROBLEM WAS A CORRODED CONNECTOR ON THE BATTERY CHARGER. THE ROOT CAUSE OF THE CORRODED CHARGER CONNECTOR WAS PROBABLY LIQUID SPILLED INTO THE WELL OF THE BATTERY CHARGER. THE BATTERY CHARGER WAS REPAIRED, RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CHARGER. THE PT RECEIVED REPLACEMENT CHARGER.

    Description of Event or Problem · 1

    THE SON OF A (B) (6) MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HE IS HAVING A BATTERY CHARGER PROBLEM. THE SON STATED THAT THERE ARE NO LIGHTS ON THE CHARGER. SUPPORT SENT A PT SERVICES REP (PSR) TO THE PT. THE PSR STATED THAT THE GREEN LIGHT ON THE POWER BRICK IS ON, BUT NO LIGHTS COME ON THE CHARGER WHEN EITHER BATTERY PACK IS INSERTED. SUPPORT HAD THE PSR REPLACE 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 78 YR