BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON ANESTHESIA CARE

    MDR report key: 3952209 · Received May 13, 2014

    Report

    Report Number
    3009662297-2014-00005
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MCKESSON TECHNOLOGIES INC.
    Product Code
    BSZ
    PMA / PMN Number
    K113633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED USING A SIMULATED TESTING ENVIRONMENT TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. THE RESULTS OF THE INVESTIGATION CONCLUDED THAT IF A USER ADDS OR EDITS COMMENTS (I.E.ONSET DATE, MOST RECENT DATE, COMMENTS, CURRENT OR PAST), THE COMMENT CHANGES WILL NOT BE RETAINED IN THE DATABASE FOR THE INTEGRATED MEDICAL HISTORY COMMENTS. THIS SITUATION OCCURS ONLY FOR CONDITIONS THAT ARE CONFIGURED WHERE THE FREQUENTLY USED NAME IS NOT EQUAL TO THE CONDITION NAME. THE APPLICATION ALLOWS THE SYSTEM ADMINISTRATOR TO CONFIGURE THE SYSTEM TO DISPLAY A FREQUENTLY USED NAME THAT WOULD DIFFER FROM THE STANDARD MEDICAL HISTORY CONDITION NAME. IT WAS DETERMINED IF THESE TWO FIELD NAMES DID NOT MATCH, COMMENTS WOULD NOT BE RETAINED. 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 OCCURRENCE WHERE CHANGES TO MEDICAL HISTORY COMMENTS ON THE MEDICAL HISTORY SCREEN OF THE PRE-ANESTHESIA EVALUATION (PAE) APPLICATION WERE NOT BEING RETAINED IN THE DATABASE. THERE WAS NO ADVERSE EVENTS OR PATIENT INJURIES RESULTANT FROM THE REPORTED ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285719 MCKESSON ANESTHESIA CARE MCKESSON ANESTHESIA CARE BSZ MCKESSON TECHNOLOGIES INC. MAC 15.0.4/15.0.4.1

    Patients

    Seq Age Sex Outcome Treatment
    1