BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENEVISION CENTRAL MONITORING SYSTEM

    MDR report key: 7576120 · Received June 6, 2018

    Report

    Report Number
    3009156722-2018-00005
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    March 23, 2018
    Report Date
    May 11, 2018
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Product Code
    MSX
    PMA / PMN Number
    K162607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    MINDRAY FIELD SERVICE REPRESENTATIVE VISITED THE SITE AND COLLECTED ERROR LOST FROM MULTIPLE SYSTEMS. AN EVALUATION IS UNDERWAY, HOWEVER, IT IS NOTED THAT THE SITE WAS UNABLE TO PROVIDE SPECIFIC INFORMATION ABOUT THE TIME OF THE EVENT, THE SYSTEM INVOLVED OR OTHER EVIDENCE OF THE EVENT SUCH AS ECG STRIPS. (B)(4). (EXEMPTION #E2015032).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT CENTRAL MONITOR SYSTEM FAILED TO ALARM WHEN A PATIENT EXPERIENCED A RUN OF VENTRICULAR RHYTHM. SOURCE OF THE REPORT: MW5076872. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416852 BENEVISION CENTRAL MONITORING SYSTEM BENEVISION MSX SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BENEVISION CENTRAL MONITORING SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1