BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A5 ANESTHESIA SYSTEM

    MDR report key: 3091178 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00609
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    October 11, 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
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPRESENTATIVES ADJUSTED THE N2O TANK REGULATOR PRESSURE. PERFORMED LEAK TESTS AND VERIFIED PROPER OPERATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE A5 ANESTHESIA SYSTEM, WHICH MAY HAVE RESULTED IN A LOSS OF N2O MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187238 A5 ANESTHESIA SYSTEM ANESTHESIA DELIVERY SYSTEM BSZ MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1