BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENEVISION CENTRAL MONITORING SYSTEM

    MDR report key: 7609478 · Received June 18, 2018

    Report

    Report Number
    3009156722-2018-00007
    Event Type
    Malfunction
    Date Received
    June 18, 2018
    Date of Event
    May 23, 2018
    Report Date
    May 23, 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
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ECG STRIPS CORRESPONDING TO THE REPORT AT 11:19:38 WERE REVIEWED BUT A DETERMINATION OF THE POSSIBLE BEAT CLASSIFICATION COULD NOT BE MADE AND NO CONCLUSIONS COULD OBTAINED. ECG STRIPS 20 SECONDS PRE AND POST THE TIME ARE NEEDED TO ASSESS BEAT CLASSIFICATION AND IF THE USER ESTABLISHED CRITERIA FOR VENTRICULAR TACHYCARDIA WERE MET, BUT THESE COULD NOT BE PROVIDED BY THE FACILITY. (B)(4). (EXEMPTION #E2015032).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2018 THE (B)(6) STATION MAY HAVE FAILED TO PRODUCE AN ALARM; AT 11:19:38 IT WAS REPORTED THAT A VENTRICULAR TACHYCARDIA ALARM WAS EXPECTED BUT NO ALARM WAS GENERATED BY THE SYSTEM. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453083 BENEVISION CENTRAL MONITORING SYSTEM BENEVISION MSX SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BENEVISION CENTRAL MONITORING SYSTEM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1