BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2081720 · Received April 11, 2011

    Report

    Report Number
    3002158293-2011-00407
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 5, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVALS OF CHARGER/MODEM SN (B)(4) AND BATTERY SN (B)(4) HAVE BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER WON'T CHARGE BATTERY) WAS CONFIRMED. UPON EVAL, THE BATTERY PACK HAD A LOW OUTPUT VOLTAGE, AND THE CHARGER WOULD NOT RECOGNIZE THE BATTERY BEING INSERTED. UPON EVAL, THE BATTERY HAD CORROSION AROUND THE CONNECTOR. THE CHARGER HAD A BURNT Q1 COMPONENT, WHICH IS THE CURRENT CONTROLLING COMPONENT OF THE CHARGER. THE CORROSION ON THE BATTERY PACK LIKELY LEAKED INTO THE CHARGER, CAUSING THE Q1 FAILURE. THE BATTERY ALSO HAD A LOW OUTPUT VOLTAGE AT 2.68 VOLTS. THE CAUSE OF THE LOW OUTPUT VOLTAGE CANNOT BE POSITIVELY DETERMINED, BUT IS LIKELY DUE TO THE IMPROPER CURRENT FLOWING FROM THE CHARGER. THE ROOT CAUSE FOR THE CORROSION CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE COMPONENTS. THE PT RECEIVED A REPLACEMENT CHARGER.

    Description of Event or Problem · 1

    A NURSE ASSISTING AN (B)(6) MALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PT'S BATTERY WAS NOT CHARGING. THE CHARGER DISPLAYED A MESSAGE TO "INSERT BATTERY." THE PT WAS SENT A REPLACEMENT CHARGER AND BATTERY.

    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 88 YR