BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENEVIEW MONITOR

    MDR report key: 3131198 · Received May 23, 2013

    Report

    Report Number
    2221819-2013-01164
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    September 7, 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 O2 MODULE. UNIT WAS CALIBRATED AND SAFETY TESTED TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE BENEVIEW MONITOR, WHICH MAY HAVE RESULTED IN LOSS OF O2 MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230017 BENEVIEW MONITOR PATIENT MONITOR MHX MINDRAY BIOMEDICAL ELECTRONICS CO.

    Patients

    Seq Age Sex Outcome Treatment
    1