BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A5 ANESTHESIA DELIVERY SYSTEM

    MDR report key: 3091395 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00485
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    September 24, 2012
    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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MONDRAY SERVICE REPRESENTATIVES REPLACED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE A5 ANESTHESIA DELIVERY SYSTEM'S O2 FLOW WHICH MAY HAVE AFFECTED O2 ANESTHESIA MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187637 A5 ANESTHESIA DELIVERY SYSTEM ANESTHESIA DELIVERY SYSTEM BSZ MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1