BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON ANESTHESIA CARE

    MDR report key: 4828312 · Received June 4, 2015

    Report

    Report Number
    3009662297-2015-00002
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 14, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MCKESSON TECHNOLOGIES INC.
    Product Code
    BSZ
    PMA / PMN Number
    K113633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY WAS UNABLE TO DUPLICATE THE ALLEGED PROBLEM OR DETERMINE ROOT CAUSE. FURTHER INVESTIGATION CONDUCTED BY THE SOFTWARE DEVELOPMENT TEAM DETERMINED THAT THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED; HOWEVER, A PLAUSIBLE EXPLANATION OF THE ERRORS IN THE DATA DISPLAYED ON THE WORKSTATION INDICATED THAT IT WAS LIKELY CAUSED BY AN ERRONEOUS INTERFACE MESSAGE RECEIVED FORM AN OUTSIDE SOURCE. IT IS BELIEVED THAT ALL INFORMATION DISPLAYED WAS CORRECT AT THE START OF THE PROCEDURE, AN INTERFACE MESSAGE RECEIVED FORM ANOTHER SOURCE CAUSED THE OVERRIDE OF THE PATIENT DEMOGRAPHIC INFORMATION. IN THIS EVENT, THE PATIENT DEMOGRAPHIC INFORMATION AFFECTED WAS THE PATIENT NAME, SEX, AND DATE OF BIRTH. THE REPORTING HOSPITAL/SITE WAS NOTIFIED OF THE RESULTS OF THE INVESTIGATION AND THE SITE WAS ABLE TO RECTIFY THE CASE XML, PATIENT DATA AND APPLICABLE REPORTS. THE COMPANY WILL CONTINUE TO INVESTIGATE. THIS IS THE FIRST REPORTED OCCURRENCE OF THIS EVENT. THERE WAS NO INJURY TO 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 THE DATA DISPLAYED IN THE PATIENT DEMOGRAPHIC SECTION OF THE ANESTHESIA CARE RECORD (ACR) CHANGED IN THE MIDDLE OF THE PATIENT CASE, AND THE NEW PATIENT DEMOGRAPHIC INFORMATION DID NOT MATCH THE ACTUAL PATIENT. 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
    363810 MCKESSON ANESTHESIA CARE MCKESSON ANESTHESIA CARE BSZ MCKESSON TECHNOLOGIES INC. MAC 15.0.4 VERSION

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK