BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION WITH TELEMETRY

    MDR report key: 4090089 · Received August 18, 2014

    Report

    Report Number
    2221819-2014-00498
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 17, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE UNIT AND IDENTIFIED AN ISSUE WITH THE FLAT PANEL DISPLAY. THE FLAT PANEL DISPLAY WAS SENT TO THE VENDOR FOR REPAIR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PANORAMA CENTRAL STATION, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496256 PANORAMA CENTRAL STATION WITH TELEMETRY CENTRAL MONITORING STATION MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1