BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENEVIEW MONITOR

    MDR report key: 3131197 · Received May 23, 2013

    Report

    Report Number
    2221819-2013-01163
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    September 27, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY BIOMEDICAL ELECTRONICS CO.
    Product Code
    MHX
    PMA / PMN Number
    092449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE UNIT AND REPLACED THE GAS BENCH. UNIT WAS CALIBRATED AND TESTED TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH BENEVIEW MONITOR, WHICH MAY HAVE AFFECTED GAS MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228474 BENEVIEW MONITOR PATIENT MONITOR MHX MINDRAY BIOMEDICAL ELECTRONICS CO.

    Patients

    Seq Age Sex Outcome Treatment
    1