BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENEVISION CENTRAL MONITORING SYSTEM

    MDR report key: 8218869 · Received January 4, 2019

    Report

    Report Number
    3009156722-2018-00011
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Report Date
    May 24, 2019
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
    Product Code
    MSX
    PMA / PMN Number
    K183238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS PENDING THE ANALYSIS OF DATA LOGS. (B)(4). (EXEMPTION #E2015032).

    Additional Manufacturer Narrative · 0

    LOGS, EGC STRIPS, AND PATIENT DATA BASE DATA WERE COLLECT FOR EVALUATION. UPON THE EVALUATION OF THE AVAILABLE DATA IT WAS CONCLUDED THAT THE PACER SPIKES ON THE SURFACE ECG WERE BELOW THE MINIMUM DETECTION THRESHOLD FOR THE TELEMETRY (2 MV AND 0.1 MSEC). CONSEQUENTLY, NO PACER SPIKES WERE DISPLAYED ON THE MONITOR. THERE WAS NO DEVICE MALFUNCTION. ADDITIONAL INVESTIGATION WAS PERFORMED WITH A DISPOSAL LEADSET PROVIDED BY THE CUSTOMER. THE LEADSET WAS MANUFACTURED BY A THIRD PARTY AND WAS OBSERVED THAT THE LEADSET HAD A CONDUCTIVE METAL MATERIAL ON ONLY ONE SIDE OF THE PINCH ELECTRODE WHICH DOES NOT COMPLY WITH THE REQUIRED STANDARDS (B)(4), SECTION 8.5.2.3. THE BENEVISION/TM80 USER MANUAL ADVISE TO USE ONLY SPECIFIED ACCESSORIES, THE THIRD PARTY LEADSET SUBJECT TO THIS INVESTIGATION IS NOT SPECIFIED. THE BENEVISION CENTRAL MONITORING SYSTEM PERFORMED AS SPECIFIED. (B)(4). (IMPORTER/REGISTRATION #(B)(4)) IS SUBMITTING THIS REPORT ON BEHALF OF SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (MANUFACTURER/REGISTRATION #(B)(4))(EXEMPTION #E2015032).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A PACEMAKER WAS BEING MONITORED ON A BENEVISION TM80 TELEMETRY TRANSMITTER. THE PACER ENHANCEMENT WAS TURNED ON BUT THERE WERE NO PACER SPIKES SEEN ON THE MONITOR. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A PACEMAKER WAS BEING MONITORED ON A BENEVISION TM80 TELEMETRY TRANSMITTER. THE PACER ENHANCEMENT WAS TURNED ON BUT THERE WERE NO PACER SPIKES SEEN ON THE MONITOR. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8986 BENEVISION CENTRAL MONITORING SYSTEM BENEVISION MSX SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BENEVISION CENTRAL MONITORING SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 CENTRAL STATION, CAT. 115-047354-00, 3CQ7411QWP| CENTRAL STATION, CAT. 115-047354-00, 3CQ7411QWP| CENTRAL STATION, CAT. 115-047354-00, 3CQ7411XK2| CENTRAL STATION, CAT. 115-047354-00, 3CQ7411XK2| CENTRAL STATION, CAT. 115-047354-00, 3CQ7411XNW| CENTRAL STATION, CAT. 115-047354-00, 3CQ7411XNW| TM80, CAT. 115-047565-00, HJD81001277| TM80, CAT. 115-047565-00, HJD81001277| TM80, CAT. 115-047565-00, HJD81001372| TM80, CAT. 115-047565-00, HJD81001372| TM80, CAT. 115-047565-00, HJD81001512| TM80, CAT. 115-047565-00, HJD81001512| TM80, CAT. 115-047565-00, HJD81001513| TM80, CAT. 115-047565-00, HJD81001513| TM80, CAT. 115-047565-00, HJD81001515| TM80, CAT. 115-047565-00, HJD81001515| TM80, CAT. 115-047565-00, HJD81001521| TM80, CAT. 115-047565-00, HJD81001521