BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3881204 · Received February 10, 2014

    Report

    Report Number
    3008642652-2014-00476
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    December 7, 2013
    Report Date
    February 7, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY/CHARGER FAULTS) WAS CONFIRMED. AS RECEIVED THE BATTERY WAS UNABLE TO COMMUNICATE. THE CAUSE OF THE FAILURE WAS ISOLATED TO AN OPEN FUSE IN THE BATTERY PACK. THE ROOT CAUSE OF THE OPEN FUSE WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY. THE PATIENT DID NOT REQUIRE A REPLACEMENT BATTERY.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENTS BATTERY WAS GIVING A FAULT ON THE CHARGER. THE PATIENT DID NOT REQUIRE A REPLACEMENT BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88632 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR