BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A5 ANESTHESIA SYSTEM

    MDR report key: 3091829 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-01048
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    123211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE UNIT AND FOUND A SMALL PLASTIC FLAGMENT IN THE O2 FLUSH VALVE BUTTON HOUSING. THE PLASTIC FLAGMENT WAS REMOVED AND THE O2 FLUSH VALVE OPERATED PROPERLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE O2 FLUSH VALVE NOT RELEASING PROPERLY, WHICH MAY HAVE AFFECTED ANESTHESIA MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186369 A5 ANESTHESIA SYSTEM ANESTHESIA DELIVERY SYSTEM BSZ MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1