BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON ANESTHESIA CARE

    MDR report key: 5053773 · Received September 3, 2015

    Report

    Report Number
    3009662297-2015-00004
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    August 12, 2015
    Report Date
    September 3, 2015
    Manufacturer
    MCKESSON TECHNOLOGIES, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K113633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 INCORRECT INFORMATION WAS DISPLAYED ON THE PAE SCREENS OF THE REPORTING FACILITY AFTER THEY CHANGED THE PAE CONFIGURATION AND DID NOT RESTART THE SERVICE. ALTHOUGH THE INFORMATION WAS INCORRECTLY DISPLAYED ON THE PAE SCREEN, THE DATABASE STORAGE AND ASSOCIATED REPORTS REFLECTED THE CORRECT PATIENT MEDICAL CONDITION DATA. THERE HAVE BEEN NO ADVERSE EVENTS OR PATIENT INJURIES RESULTANT FORM THE REPORTED ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    A CUSTOMER SITE REPORTED THAT A MEDICAL HISTORY CONDITION DATA ON THE MEDICAL HISTORY SCREEN OF THE PRE-ANESTHESIA EVALUATION (PAE) APPLICATION DID NOT REFLECT THE CORRECT CONDITIONS. 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
    586666 MCKESSON ANESTHESIA CARE MCKESSON ANESTHESIA CARE BSZ MCKESSON TECHNOLOGIES, INC. MAC 15.0.4 VERSION

    Patients

    Seq Age Sex Outcome Treatment
    1