BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMS-6016 MONITOR

    MDR report key: 3091828 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-01051
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    080192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE UNIT AND REPLACED THE TELEPACK'S RECEIVER BOARD.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DPM CENTRAL STATION HAD SIGNAL STRENGTH PROBLEM WITH THE RECEIVER CHANNELS, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187080 TMS-6016 MONITOR CENTRAL MONITORING STATION MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1