BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENEVIEW MONITOR

    MDR report key: 3091099 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00867
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SHENZHEN BIOMEDICAL ELECTRONICS CO.
    Product Code
    MHX
    PMA / PMN Number
    092449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPRESENTATIVE CALIBRATED AND PERFORMANCE TESTED UNIT TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE BENEVIEW MONITOR DISPLAYED INACCURATE AGENT AND N2O READINGS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187839 BENEVIEW MONITOR PATIENT MONITOR MHX SHENZHEN BIOMEDICAL ELECTRONICS CO.

    Patients

    Seq Age Sex Outcome Treatment
    1