BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPM CENTRAL STATION

    MDR report key: 3102689 · Received May 1, 2013

    Report

    Report Number
    2221819-2013-01040
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MSX
    PMA / PMN Number
    080192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE SYSTEM. CORRECTIONS INCLUDED REPLACEMENT OF THE SYSTEM'S POWER OUTLET AND REBOOTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DPM CENTRAL STATION HAD A BLANK SCREEN AND SHUT DOWN, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189508 DPM CENTRAL STATION CENTRAL MONITORING STATION MSX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1