BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPM CENTRAL STATION

    MDR report key: 3102683 · Received May 1, 2013

    Report

    Report Number
    2221819-2013-01030
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC
    Product Code
    MSX
    PMA / PMN Number
    080192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THAT THE CUSTOMER HAD REMOVED THE PT FROM A DPM BEDSIDE MONITOR TO PERFORM CARDIOVERSION AND DID NOT READMIT THE PT BACK TO THE SYSTEM; THEREFORE, NO DATA WAS AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY WERE UNABLE TO OBTAIN COMPLETE TRENDED DATA FROM THE DPM CENTRAL STATION ON A PT WHO EXPIRED. CUSTOMER DID NOT ATTRIBUTE THE PT'S DEATH TO THE DEVICE AND NO DEVICE MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190719 DPM CENTRAL STATION CENTRAL MONITORING STATION MSX MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1