BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANESTAR ANESTHESIA DELIVERY SYSTEM

    MDR report key: 3102663 · Received May 1, 2013

    Report

    Report Number
    2221819-2013-01055
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    001988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPRESENTATIVE REPLACED A FUSE, CHECKED AND TESTED THE UNIT TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ERROR MESSAGED WAS DISPLAYED ON THE ANESTAR ANESTHESIA DELIVERY SYSTEM, WHICH MAY HAVE IMPACTED ANESTHESIA MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189392 ANESTAR ANESTHESIA DELIVERY SYSTEM ANESTHESIA DELIVERY SYSTEM BSZ MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1