BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON ANESTHESIA CARE

    MDR report key: 3645333 · Received January 10, 2014

    Report

    Report Number
    3009662297-2014-00002
    Event Type
    Malfunction
    Date Received
    January 10, 2014
    Date of Event
    December 12, 2013
    Report Date
    January 10, 2014
    Manufacturer
    MCKESSON TECHNOLOGIES INC.
    Product Code
    BSZ
    PMA / PMN Number
    K113633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 INCORRECT INFORMATION WAS DISPLAYED ON THE PAE SCREENS OF THE REPORTING FACILITY. ALTHOUGH THE INFORMATION WAS INCORRECTLY DISPLAYED ON THE PAE SCREEN, THE DATABASE STORAGE AND ASSOCIATED REPORTS REFLECTED THE CORRECT PATIENT MEDICAL CONDITION DATA. THE ACTUAL DEFECT DID NOT OCCUR EVERY TIME AND WAS SPORADIC IN NATURE. FURTHER ANALYSIS DETERMINED THAT THE MALFUNCTION WAS LIKELY CAUSED BY A DEFECT IN THE DEVICE SOFTWARE. THERE HAVE BEEN NO ADVERSE EVENTS OR PATIENT INJURIES RESULTANT FROM THE REPORTED ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    A CUSTOMER SITE REPORTED THAT 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
    20552 MCKESSON ANESTHESIA CARE MCKESSON ANESTHESIA CARE BSZ MCKESSON TECHNOLOGIES INC. MAC 15.0.4 VERSION

    Patients

    Seq Age Sex Outcome Treatment
    1