BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3190989 · Received June 21, 2013

    Report

    Report Number
    3008642652-2013-01642
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 19, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY NOT CHARGING) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY PACK WAS UNABLE TO RECHARGE OR POWER UP A MONITOR. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A CORRUPTED BQ2040 BATTERY CHIP. THE ROOT CAUSE FOR THE CORRUPT BQ2040 BATTERY CHIP COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPT BATTERY CHIP. THE PT REC'D A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT ONE OF THE PT'S BATTERY PACKS WAS NOT CHARGING. THE PT WAS ISSUED A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283180 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR