BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON ANESTHESIA CARE

    MDR report key: 5192036 · Received October 30, 2015

    Report

    Report Number
    3009662297-2015-00005
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 6, 2015
    Report Date
    October 30, 2015
    Manufacturer
    MCKESSON TECHNOLOGIES, INC
    Product Code
    BSZ
    PMA / PMN Number
    K113633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED USING A TESTING ENVIRONMENT TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. THE REPORTED PROBLEM WAS REPRODUCIBLE ONLY DURING INTRAOP STAGE USAGE OF THE DEVICE (AT THE SITE) WHILE LIVE PHYSIOLOGICAL DATA WAS BEING RECEIVED. THE ANESTHESIA CARE RECORD ONLY DISPLAYED THE INACCURATE GRID DESCRIPTOR LINE, IF THE RECORD WAS BEING EDITED DURING THE RECEIPT OF MEASUREMENT DATA. AT THIS TIME, THE REPORTING FACILITY HAS BEEN ASKED TO ADJUST THEIR PHYSICIAN WORK-FLOW STEPS NOT TO EDIT THE DESCRIPTIONS IN THE ANESTHESIA CARE RECORD DURING ANY PHASES WHERE MEASUREMENT DATA IS RECEIVED. A REVIEW OF COMPLAINTS REVEALED THAT THIS IS THE FIRST COMPLAINT RECEIVED FOR THE REPORTED EVENT TO DATE. ADDITIONALLY, THERE HAVE BEEN NO REPORTED ADVERSE HEALTH EVENTS OR PATIENT INJURIES RESULTING FROM THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER SITE REPORTED THE ANESTHESIA CARE RECORD ACCURATELY DISPLAYED THE MEASUREMENT DATA RECEIVED. HOWEVER, THE ANESTHESIA CARE RECORD DISPLAYED THE MEASUREMENT DATA ON THE INCORRECT DESCRIPTION LINE IN THE GRID/GRAPH WHEN PATIENT RECORDS WERE BEING EDITED BY THE REPORTING FACILITY. THERE WERE NO ADVERSE EVENTS OR PATIENT HARM RESULTANT FROM THE REPORTED ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722973 MCKESSON ANESTHESIA CARE MCKESSON ANESTHESIA CARE BSZ MCKESSON TECHNOLOGIES, INC MAC VERSION 15.1.1.2

    Patients

    Seq Age Sex Outcome Treatment
    1