BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS ANESTHESIA SYSTEM (PAS)

    MDR report key: 2030301 · Received March 21, 2011

    Report

    Report Number
    2016493-2011-00025
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    CAREFUSION
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L DATA: PER CUSTOMER REPORT - CUSTOMER INDICATED THAT UPON INITIAL ATTEMPT TO LOGIN TOUCHSCREEN WAS FROZEN WITH A MESSAGE DISPLAYED REGARDING TUTORIAL. REBOOT WAS THE SUCCESSFUL RESOLUTION. UPON FURTHER REVIEW, IT WAS DETERMINED THIS CASE WAS MDR REPORTABLE.

    Description of Event or Problem · 1

    USER REPORTS INABILITY TO LOGIN TO THE PYXIS ANESTHESIA SYSTEM IN AN EFFORT TO ACCESS MEDICATIONS. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PYXIS ANESTHESIA SYSTEM (PAS) AUTOMATED DISPENSING CABINET (ADC'S) BRY CAREFUSION 3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK