BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS3000 ANESTHESIA SYSTEM

    MDR report key: 3091794 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-01080
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    080175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE UNIT AND REPLACED THE UNIT'S FLOW METER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE AS3000 ANESTHESIA DELIVERY SYSTEM DISPLAYED INACCURATE GAS READINGS, WHICH MAY HAVE AFFECTED ANESTHESIA MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188191 AS3000 ANESTHESIA SYSTEM ANESTHESIA DELIVERY SYSTEM BSZ MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1