BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3191028 · Received June 21, 2013

    Report

    Report Number
    3008642652-2013-01669
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 2, 2013
    Report Date
    June 20, 2013
    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 EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER FAULTS) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER WAS UNABLE TO CHARGE A BATTERY PACK. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A DEFECTIVE RESISTOR R11. THE R11 RESISTOR WAS BROKEN FREE FROM THE PCA BOARD. THE ROOT CAUSE FOR THE DETACHED RESISTOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED R11 RESISTOR. THE PT REC'D A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    DOWNLOAD DATA FROM A (B)(6) MALE PT REVEALED SEVERAL BATTERY CHARGER FAULTS. ZOLL CUSTOMER SUPPORT CONTACTED THE PT AND ISSUED HIM A REPLACEMENT BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283445 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR