BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS ANESTHESIA SYSTEM (PAS)

    MDR report key: 2091419 · Received May 6, 2011

    Report

    Report Number
    2016493-2011-00046
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    CAREFUSION
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL DATA / FAILURE INVESTIGATION. FIELD SERVICE TECHNICIAN INVESTIGATION DISCOVERED PHYSICAL ITEM OBSTRUCTION CAUSING DRAWER FAILURE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DRAWER ON PYXIS ANESTHESIA SYSTEM FAILED. NO PATIENT PRESENT.

    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