BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPM CENTRAL STATION W/ TELEPACK

    MDR report key: 3091209 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00788
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    February 28, 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 REP EVALUATED AND REBOOTED THE SYSTEM. SYSTEM WAS SAFETY TESTED TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DPM CENTRAL STATION'S DISPLAY HAD AN ALARM EVENT STUCK ON THE SCREEN, WHICH MAY HAVE RESULTED IN LOSS OF TELEMETRY MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188148 DPM CENTRAL STATION W/ TELEPACK CENTRAL MONITORING STATION MSX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1