BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EP WORKMATE ELECTROPHYSIOLOGY RECORDING SYSTEM

    MDR report key: 2923275 · Received October 31, 2006

    Report

    Report Number
    2248049-2006-00004
    Event Type
    Injury
    Date Received
    October 31, 2006
    Date of Event
    July 15, 2005
    Report Date
    October 31, 2006
    Manufacturer
    EP MEDSYSTEMS, INC.
    Product Code
    DQK
    Removal / Correction Number
    Z-0914-06
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EP-4 (DEVICE 1) WAS INVESTIGATED, NO FAILURE MODE OBSERVED OR IDENTIFIED FOR THIS DEVICE. SUBJECT DEVICE REPAIRED AND MODIFIED AS PART OF SUBSEQUENT FIRM INITIATED DEVICE RECALL. SIGNAL CONDITIONING UNIT (SCU) (DEVICE 2) WAS IDENTIFIED AS CAUSE OF THE EVENT. HOWEVER, BASED ON INFORMATION ABOUT THE EP-4 GAINED THROUGH LATER INVESTIGATIONS, IT IS BELIEVED THAT THE SCU SUFFERED DAMAGE IN SHIPPING, BUT WOULD NOT HAVE CAUSED THE TYPE OF PROBLEM REPORTED BY THE USER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED EP-4 DELIVERED AN [UNEXPECTED] OUTPUT WHEN A STIMULATION CHANNEL WAS SELECTED. PATIENT EXPERIENCED ATRIAL FIBRILLATION. REFERENCE REPORT 2248049-2006-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EP WORKMATE ELECTROPHYSIOLOGY RECORDING SYSTEM DQK EP MEDSYSTEMS, INC. EP WORKMATE 120

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention