BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON ANESTHESIA CARE

    MDR report key: 3565659 · Received October 10, 2013

    Report

    Report Number
    3009662297-2013-00002
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Date of Event
    August 12, 2013
    Report Date
    October 10, 2013
    Manufacturer
    MCKESSON TECHNOLOGIES INC.
    Product Code
    BSZ
    PMA / PMN Number
    K113633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, IT WAS DETERMINED THAT IF THE USER'S PASSWORD CONTAINS ANY OF THE FOLLOWING CHARACTERS: PLUS SIGN (+), SINGLE RIGHT QUOTE ('), BACKSPACE (\), DATA ENTERED OR EDITED BY THE INDIVIDUAL USER ON THE MEDICAL HISTORY SCREEN OF THE PRE-ANESTHESIA EVALUATION (PAE) MODULE IS NOT RETAINED. THIS INFO WAS REPORTED BACK TO THE REPORTING ANESTHESIOLOGIST; HE CONFIRMED THE USE OF THE CHARACTERS IN HIS PASSWORD AND CHANGED HIS PASSWORD. BASED ON THE UPDATE OF THE USER'S PASSWORD, THE MCKESSON ANESTHESIA CARE (MAC) SOFTWARE APPLICATION FUNCTIONED AS INTENDED FOR THE USER. A HISTORICAL REVIEW OF COMPLAINTS INDICATED THAT THIS IS THE FIRST REPORTED COMPLAINT RECEIVED OF THIS NATURE. THERE WAS NO INJURY ON THE ACTUAL PT AND/OR NO DELAY IN PT CARE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY ONE CUSTOMER SITE OF AN OCCURRENCE WHERE A SINGLE USER WAS UNABLE TO RETAIN ANY MEDICAL HISTORY COMMENTS IN THE MEDICAL HISTORY SCREEN OF PRE-ANESTHESIA EVALUATION (PAE) APPLICATION. THERE WERE NO ADVERSE EVENTS OR PT INJURIES RESULTANT FROM THE REPORTED ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519926 MCKESSON ANESTHESIA CARE BSZ MCKESSON TECHNOLOGIES INC. MAC 14.3X VERSIONS

    Patients

    Seq Age Sex Outcome Treatment
    1