BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V21 MONITOR

    MDR report key: 3874179 · Received June 11, 2014

    Report

    Report Number
    MW5036598
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MINDRAY
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT IN TRAUMA ROOM IN (B)(6). PATIENT REQUIRES MONITORING OF VITAL SIGNS. THE MONITORS AND DOCKING STATIONS WERE INSTALLED BY MINDRAY. THE V21 MINDRAY MONITOR WAS TURNED ON BY (B)(6) RN. THE MONITOR WAS PUSHED SLIGHTLY BY THE (B)(6) RN. THE MONITOR FELL OFF ITS DOCKING STATION AND FELL DOWNWARD, NARROWLY MISSING A PATIENT. THE UNIT CRASHED TO THE FLOOR AND BROKE. THE UNIT WEIGHT IS 21 POUNDS AND THIS INCIDENT CAUSED GREAT CONCERN TO STAFF REGARDING THE SAFETY OF THIS EQUIPMENT. THE DOCKING UNIT WAS INSPECTED AND FOUND TO NOT HAVE ANY ISSUES OR CONCERNS. NOTHING WAS BROKEN, "NOTHING WAS WORN" AND IS INTACT. THIS WAS REPORTED TO MINDRAY ON (B)(6) 2014 AND WE AWAIT RESPONSE FROM MINDRAY AS OF (B)(4) 2014. THE DESIGN OF THE UNIT IS IN QUESTION. BOTH THE DOCKING STATION AND THE MONITOR ITSELF. THE DOCKING PINS ARE VERY SMALL AND MUST HOLD A 21 POUND MONITOR WITH NO OTHER SAFETY DEVICE ATTACHED TO PREVENT FALLING. ALSO, THE DESIGN OF THE V21 MONITOR ITSELF: ON THE BACK OF THE MONITOR ARE TWO "HANDLES" THAT CAN BE USED TO DETACH THE MONITOR FROM ITS DOCKING STATION TO REMOVE AND BE TRANSPORTED WITH A PATIENT IF NEEDED. THE NATURAL DESIGN OF THIS MONITOR SUGGESTS THAT A PERSON WANTING TO SIMPLY MOVE THE MONITOR MAY UNINTENTIONALLY GRASP THE HANDLE AT THE BACK OF THE MONITOR, CAUSING POSSIBLE DETACHMENT FROM THE DOCKING STATION. STAFF AT OUR HOSPITAL WENT TO ALL PATIENT ROOM TO ENSURE THAT EACH V21 WAS ATTACHED TO THE DOCKING STATION APPROPRIATELY. OTHER SMALLER MINDRAY MONITORS HAVE A SEPARATE SAFETY "PIN" THAT HELPS PREVENT THE MONITOR FROM FALLING INTO A PATIENT. WE ARE CONCERNED FOR THE SAFETY OF THIS V21 MONITOR WITH OUR CURRENT SET-UP. WE MAY HAVE TO RESORT TO OTHER MECHANISMS TO KEEP THE MONITORS FROM DETACHING INAPPROPRIATELY FROM THE DOCKING STATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344166 V21 MONITOR MONITOR MHX MINDRAY V21
    344420 V DOCK V DOCK MHX MINDRAY V DOCK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening