BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823580 · Received May 1, 2014

    Report

    Report Number
    3008642652-2014-01346
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (NOT CHARGING BATTERIES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS UNABLE TO CHARGE A BATTERY. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A SHORTED Q1 CURRENT-CONTROLLING TRANSISTOR ON THE BEDSIDE PCA BOARD. THE ROOT CAUSE FOR THE SHORTED Q1 TRANSISTOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE SHORTED Q1 TRANSISTOR. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S SPOUSE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S BATTERY CHARGER WAS NOT FUNCTIONING PROPERLY. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261021 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR