BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEC-2000 PATIENT MONITOR

    MDR report key: 4090051 · Received August 18, 2014

    Report

    Report Number
    3007222337-2014-00005
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    May 5, 2014
    Report Date
    August 14, 2014
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE TEAM HAS PERFORMED AN ONSITE INVESTIGATION WITH THE EVENT AND REALIZED BELOW SCENARIO. THE HOSPITAL WAS USING THE NEC-2000 TO MONITOR A PT ON (B)(4) 2014, SUDDENLY THERE'S BLACK SCREEN APPEARED, THE LCD COULD NOT DISPLAY ANYTHING. THE HOSPITAL FACILITY TECH CAME TO INSPECT THE DEVICE, HE OPENED THE DEVICE AND FOUND THE LCD SIGNAL CABLE WAS DISCONNECTED, THEN HE PLUGGED THE CABLE TO THE LCD AND ADDED HOTMELT TO FIX IT. THEN THE DEVICE CAN BE DISPLAYED AND WORKED PROPERLY. MINDRAY SERVICE ENGINEER REOPENED THE DEVICE IN THE HOSPITAL, INSPECTED THE LCD SIGNAL TO THE SOCKET. THEN HE BOOTED THE MONITOR AND INSPECTED ITS DISPLAY, THE MONITOR COULD BE DISPLAYED PROPERLY, THE FAILURE COULDN'T BE REPRODUCED THEN. UNDER THIS FAILURE MODE, THE LCD WOULD HAVE BLACK SCREEN AND CAN'T BE DISPLAYED, BUT THE ALARM FUNCTION WOULD NOT BE AFFECTED. MINDRAY WAS DISTRIBUTED MORE THAN 38000PCS OF MEC-2000 PT MONITORS, THIS IS THE FIRST TIME WE HAVE RECEIVED THIS KIND OF COMPLAINT. WE CONCLUDED IT'S AN ISOLATED CASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THE MEC-2000 WAS MONITORING A PT IN THE HOSPITAL, THE MONITOR COULD NOT BE DISPLAYED. THE DOCTOR REPLACED ANOTHER MONITOR TO USE ON THE PT. NO PT WAS DEAD OR INJURED. MEC-2000 IS NOT MARKETED IN THE USA, BUT WE HAVE SIMILAR PT MONITOR MARKETED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496317 MEC-2000 PATIENT MONITOR PATIENT MONITOR MHX SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD

    Patients

    Seq Age Sex Outcome Treatment
    1