BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2881185 · Received November 16, 2012

    Report

    Report Number
    3008642652-2012-03001
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE BATTERY CHARGER WAS RESETTING. UPON SERVICE INVESTIGATION, THE BATTERY CHARGERS BATTERY BOARD WAS DEFECTIVE. IN ADDITION D2, A TRANSIENT VOLTAGE SUPPRESSOR WAS DEFECTIVE. THIS PREVENTED THE CHARGER FROM RECOGNIZING A BATTERY PACK. THE ROOT CAUSE OF THE DEFECTIVE COMPONENTS WAS UNABLE TO BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER. THE LAST PT TO USE THIS BATTERY CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, BATTERY CHARGER/MODEM SN (B)(4) WAS RESETTING. THE LAST PT TO USE THIS BATTERY CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    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 NA