BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON ANESTHESIA CARE

    MDR report key: 3538980 · Received November 4, 2013

    Report

    Report Number
    3009662297-2013-00003
    Event Type
    Malfunction
    Date Received
    November 4, 2013
    Date of Event
    October 18, 2013
    Report Date
    November 4, 2013
    Manufacturer
    MCKESSON TECHNOLOGIES INC.
    Product Code
    BSZ
    PMA / PMN Number
    K113633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, IT WAS DETERMINED THAT WHEN THE ANESTHESIA CARE RECORD (ACR) APPLICATION IS INSTALLED ON A WORKSTATION RUNNING (B)(4), THE ACR APPLICATION WILL FAIL TO RETAIN CASE DATA IF THE USER HOVERS HIS/HER MOUSE OVER THE NOTES (COMMENTS) PANE, THE MESSAGES PANE, OR THE FLUID INTAKE/OUTPUT SCREEN AND A TOOL TIP IS DISPLAYED. AS A RESULT, DURING THIS PERIOD OF INACTIVITY, CASE DATA FROM THE PHYSIOLOGICAL MONITORS ARE NOT RECORDED AND CASE DATA UPDATES RECEIVED FROM OTHER SYSTEMS (VIA INTERFACES AND INTEGRATION) ARE NOT RETAINED ON THE WORKSTATION. WHEN THE USER'S MOUSE IS RE-POSITIONED, THE APPLICATION WILL RETURN TO ITS ACTIVE STATE AND BEGIN TO RETAIN CASE DATA. THE REPORTING HOSPITAL SITE WAS NOTIFIED OF THE RESULTS OF THE INVESTIGATION AND THE POTENTIAL OF THE ACR SCREEN TO BECOME UNRESPONSIVE. TYPICALLY THE ACR APPLICATION IS USED AS TOUCH-SCREEN APPLICATION WHERE THE MOUSE IS RARELY UTILIZED. THIS EVENT WILL NOT OCCUR ON A WORKSTATION WHEN THE USER IS USING A TOUCH-SCREEN MONITOR WITHOUT A MOUSE. THERE WAS NO INJURY ON THE ACTUAL PATIENT AND/OR NO DELAY IN PATIENT CARE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY ONE CUSTOMER SITE OF AN ALLEGED LOSS OF DATA BETWEEN OUR COMPANY'S SOFTWARE APPLICATION AND ANOTHER VENDOR'S PHYSIOLOGICAL DEVICE. THERE WERE NO ADVERSE EVENTS OR PATIENT INJURIES RESULTANT FROM THE REPORTED ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568167 MCKESSON ANESTHESIA CARE BSZ MCKESSON TECHNOLOGIES INC. MAC 15.X VERSIONS

    Patients

    Seq Age Sex Outcome Treatment
    1