BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3961198 · Received May 28, 2014

    Report

    Report Number
    3008642652-2014-01602
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER SN (B)(4) WAS COMPLETED. THE REPORTED PROBLEM (WON'T CHARGE BATTERIES WAS CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER WAS UNABLE TO RECHARGE A BATTERY PACK. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A BROKEN L4 INDUCTOR ON THE CHARGER PCA BOARD. THE ROOT CAUSE FOR THE DAMAGED L4 COMPONENT COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM THE CHARGER IMPACTING A HARD SURFACE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE L4 COMPONENT. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER BATTERY PACK WOULD NOT CHARGE. THE PATIENT WAS PROVIDED WITH A REPLACEMENT CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314923 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR