BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1911477 · Received November 18, 2010

    Report

    Report Number
    3002158293-2010-01224
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATTERY PACK (B)(4) MANUFACTURE DATE: (B)(4) 2010. BATTERY CHARGER (B)(4) MANUFACTURE DATE: (B)(4) 2010. DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY/CHARGER FAULTS) HAS BEEN CONFIRMED. UPON EVAL, LIQUID CONTAMINATION WAS FOUND ON THE BATTERY BOARD, WHICH HAD DAMAGED SEVERAL COMPONENTS. THE ROOT CAUSE OF THE CONTAMINATION WAS LIKELY A RESULT OF LIQUID INGRESS ON THE CHARGER. THE SOURCE OF THE LIQUID INGRESS COULD NOT BE POSITIVELY IDENTIFIED. DEVICE EVAL OF BATTERY PACK (B)(4) IS STILL UNDERWAY. THE REPORTED PROBLEM (BATTERY/CHARGER FAULTS) HAS BEEN CONFIRMED. THE ROOT CAUSE OF THE BATTERY FAULTS (0F80 AND 0F40) IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER OR BATTERY PACK.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) MALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT ONE OF THE PT'S BATTERIES WOULD NOT CHARGE AND MINUTES LATER REPORTED THAT THE CHARGER WOULD NOT RECOGNIZE EITHER OF THE PT'S BATTERIES. THE PT WAS PROVIDED WITH A REPLACEMENT BATTERY CHARGER AND BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR