BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENEVIEW MONITOR

    MDR report key: 3091714 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00850
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    January 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY BIOMEDICAL ELECTRONICS CO.
    Product Code
    MHX
    PMA / PMN Number
    092449
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SVC REP CALIBRATED AND TESTED THE UNIT TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE BENEVIEW MONITOR'S N2O AND AGENT READINGS ARE INACCURATE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187803 BENEVIEW MONITOR PATIENT MONITOR MHX MINDRAY BIOMEDICAL ELECTRONICS CO.

    Patients

    Seq Age Sex Outcome Treatment
    1