BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS3000 ANESTHESIA SYSTEM

    MDR report key: 3091627 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00722
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    November 29, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    080175
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SERVICE REPS REPLACED THE APL VALVE. OPERATION WAS VALIDATED AND UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE APL VALVE ON THE AS3000 ANESTHESIA SYSTEM FAILED WHICH MAY HAVE AFFECTED ANESTHESIA MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187195 AS3000 ANESTHESIA SYSTEM ANESTHESIA DELIVERY SYSTEM BSZ MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1