BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANESTAR ANESTHESIA SYSTEM

    MDR report key: 3091346 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00992
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    October 12, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    001988
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REP EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENT OF THE PROPORTIONAL VALVE. UNIT WAS CALIBRATED AND SAFETY TESTED TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ANESTAR ANESTHESIA DELIVERY SYSTEM DISPLAYED A FLOW ERROR, WHICH MAY HAVE AFFECTED ANESTHESIA MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186555 ANESTAR ANESTHESIA SYSTEM ANESTHESIA SYSTEM BSZ MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1