BEUDAMED
    FDA Adverse Event Summary report: N

    AS3000

    MDR report key: 3092098 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00461
    Date Received
    April 30, 2013
    Date of Event
    December 20, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DDS USA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    080175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPRESENTATIVES EVALUATED THE AS300 SYSTEM AND FOUND A KINK IN THE BREATHING SYSTEM PNEUMATIC AFFECTING THE INSPIRATORY SENSOR. UNIT PASSED ALL CALIBRATION, FUNCTIONAL AND SAFETY TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE AS300 ANESTHESIA SYSTEM DISPLAYED A COMMUNICATION ERROR WHICH MAY HAVE RESULTED IN A LOSS OF ANESTHESIA MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186854 AS3000 ANESTHESIA DELIVERY SYSTEM BSZ MINDRAY DDS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1