BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2881109 · Received November 16, 2012

    Report

    Report Number
    3008642652-2012-03000
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 28, 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 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 (BATTERY WON'T HOLD CHARGE) HAS BEEN CONFIRMED. UPON EVAL, COMPONENTS Q1 WAS OPEN. THE Q1 TRANSISTOR CONTROLS THE CURRENT FLOW TO THE BATTERY WHILE CHARGING. THE OPEN TRANSISTOR PREVENTED THE BATTERY CHARGER FROM CHARGING A BATTERY PACK. THE ROOT CAUSE OF THE OPEN Q1 TRANSISTOR CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED TRANSISTOR. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) MALE PT'S SON CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S BATTERY CHARGER WAS NOT CHARGING THE PT'S BATTERY PACKS. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR