BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2920562 · Received December 7, 2012

    Report

    Report Number
    3008642652-2012-03225
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 12, 2012
    Report Date
    December 4, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY FAULTS) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY PACK WAS UNABLE TO RECHARGE OR POWER UP A TEST MONITOR. A ROOT CAUSE INVESTIGATION IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE ROOT CAUSE ANALYSIS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A ZOLL PT SVC REP (PSR) CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PT WAS RECEIVING BATTERY FAULTS. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR