BEUDAMED
    FDA Adverse Event Death Summary report: N

    BENEVISION CENTRAL MONITORING SYSTEM

    MDR report key: 6505392 · Received April 19, 2017

    Report

    Report Number
    3007222337-2017-00011
    Event Type
    Death
    Date Received
    April 19, 2017
    Date of Event
    March 20, 2017
    Report Date
    March 24, 2017
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS, LTD.
    Product Code
    MSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ON SITE INVESTIGATION WAS PERFORMED BY MINDRAY SERVICE ENGINEER AND NO ANOMALY WAS FOUND ON THE TM80 TELEMETRY MONITORING SYSTEM AND THE BENEVISION CMS. THE LOG FILES AND THE PATIENT WAVEFORM WERE RETURNED FOR ANALYSIS AND IT WAS FOUND THAT AT THE 22:51:49, (B)(6) 2017, THERE WAS A "ECG LEAD OFF" ALARM INITIATED AND THE ECG LEAD WAS RECONNECTED ABOUT AN HOUR AND A HALF LATER (0:18:22, (B)(6) 2017). AFTER THE ECG LEADS WERE RECONNECTED, THE CMS RECEIVED "ASYSTOLE" ALARMS. AT 00:24:32, (B)(6) 2017, THERE WAS AN OPERATION "PRESS THE ALARM MUTE" IN THE LOG, WHICH INDICATED THE ALARM SOUND HAD BEEN TURNED OFF AT THAT TIME. ACCORDING TO ABOVE MENTIONED ANALYSIS ,WE CONCLUDED THAT THE TM80 AND THE CMS WERE WORKING PROPERLY. NO MALFUNCTION WAS FOUND.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING (B)(6) AT 10:00 PM TO (B)(6) AT 2:00 AM, A PATIENT DIED WHILE BEING MONITORED WITH THE TM80 TELEMETRY MONITORING SYSTEM. THE BENEVISION CENTRAL MONITORING SYSTEM DID NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286884 BENEVISION CENTRAL MONITORING SYSTEM CENTRAL MONITORING SYSTEM MSX SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death