BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER INFORMATION MANAGEMENT PHYSIOMONITORING 5 SYSTEM

    MDR report key: 4143203 · Received September 19, 2014

    Report

    Report Number
    4143203
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    April 25, 2014
    Report Date
    August 22, 2014
    Manufacturer
    WITT BIOMEDICAL CORPORATION
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585129 XPER INFORMATION MANAGEMENT PHYSIOMONITORING 5 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK WITT BIOMEDICAL CORPORATION HOST PC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR