BEUDAMED
    FDA Adverse Event Death Summary report: N

    BENEVISION CENTRAL MONITORING SYSTEM

    MDR report key: 7577371 · Received June 7, 2018

    Report

    Report Number
    3009156722-2018-00006
    Event Type
    Death
    Date Received
    June 7, 2018
    Date of Event
    May 12, 2018
    Report Date
    May 14, 2018
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Product Code
    MSX
    PMA / PMN Number
    K162607
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANY SERVICE REPRESENTATIVE EVALUATED THE SYSTEM AND CONFIRMED THE UNIT WAS GENERATING VISUAL AND AUDIBLE ALARMS. THE COMPANY SERVICE REPRESENTATIVE INCREASED THE VOLUME AND LOCKED THE DISPLAY WITH THE AUTHORITY OF CUSTOMER BIOMED PRESENT AND A NEW PASSWORD WAS RESET. THE CUSTOMER IS NOT ALLEGING ANY DEVICE MALFUNCTION AND REPORTED THAT NO ADDITIONAL INFORMATION WILL BE AVAILABLE. THE OPERATIVE MANUAL PROVIDES A WARNING TO REMIND THE USER OF THE RISK OF SETTING ALARM VOLUME TO A LOW LEVEL. THERE WAS NO DEVICE MALFUNCTION. (B)(4). (EXEMPTION #E2015032).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE AUDIO LEVEL IN THE DISPLAY MENU OF THE CENTRAL MONITORING STATION HAD BEEN TURNED DOWN AND A PATIENT BEING MONITORED ON THE SYSTEM EXPIRED. NOTE: THE CUSTOMER DOES NOT ALLEGE THAT THE SYSTEM MISSED AN ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419868 BENEVISION CENTRAL MONITORING SYSTEM BENEVISION MSX SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BENEVISION CENTRAL MONITORING SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death