BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2912935 · Received November 30, 2012

    Report

    Report Number
    3008642652-2012-03118
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 26, 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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON¿T POWER ON) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WOULD NOT POWER ON PAST THE START-UP SCREEN. UPON EVALUATION, THE SD CARD WAS CORRUPTED. THE CAUSE OF THE INABILITY TO POWER ON IS THE CORRUPTED SD CARD. THE ROOT CAUSE OF THE CORRUPTED SD CARD CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE SD CARD. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WOULD NOT POWER ON PAST THE START-UP SCREEN. PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR