BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3221512 · Received July 2, 2013

    Report

    Report Number
    3008642652-2013-01756
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY WON'T HOLD A CHARGE) 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 PATIENT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY PACK WOULD NOT HOLD A CHARGE. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300961 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR