BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2212450 · Received March 9, 2007

    Report

    Report Number
    3002158293-2007-00053
    Event Type
    Malfunction
    Date Received
    March 9, 2007
    Date of Event
    December 30, 2006
    Report Date
    March 9, 2007
    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 MANUFACTURE DATES: BATTERY CHARGER SN (B)(4) - 01/2006. BATTERY PACK SN (B)(4) - 11/2004. BATTERY PACK SN (B)(4) - 11/2005. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF CHARGER SN (B)(4) AND BATTERY PACKS SN (B)(4), HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE RED BAD BATTERY ICON BRIEFLY ILLUMINATING, THEN ALL LIGHTS GOING OFF, WAS CORRODED BATTERY CONTACT TERMINALS IN THE BATTERY CONNECTOR OF THE CHARGER. THE CORROSION PREVENTED PROPER CONTACT WITH THE BATTERY PACK CONNECTOR CONTACTS. THE ROOT CAUSE OF THE CORRODED TERMINALS WAS LIQUID SPILLAGE INTO THE BATTERY WELL AREA OF THE CHARGER. BATTERY PACKS SN (B)(4) PASSED ALL FUNCTIONAL TESTS. NO ADVERSE EVENT RESULTED FORM THE DAMAGED CHARGER. THE PATIENT RECEIVED REPLACEMENT BATTERY PACKS AND CHARGER.

    Description of Event or Problem · 1

    A LIFECOR SALES REPRESENTATIVE CONTACTED CUSTOMER SUPPORT TO REPORT THAT WHEN EITHER OF THE (B)(6) FEMALE PATIENT'S BATTERY PACKS ARE PLACED IN THE CHARGER THE CHARGER BRIEFLY DISPLAYS THE RED BAD BATTERY ICON THEN ALL LIGHTS GO OFF. NEITHER BATTERY PACK WILL CHARGE. THE CHARGER'S CABLE CONNECTIONS WERE CHECKED, ALL SEEMED OK. THE SALES REP. REPLACED THE PATIENT'S CHARGER AND BATTERY PACKS FOR EVALUATION.

    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 66 YR