BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS3000 ANESTHESIA SYSTEM

    MDR report key: 3091245 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00592
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    February 15, 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

    MINDRAY SERVICE REPS EVALUATED THE UNIT AND COULD NOT REPRODUCE THE ISSUE. UNIT CHECKED TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE AS3000 ANESTHESIA SYSTEM DELIVERED AN INCORRECT FIO2 MEASUREMENT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187593 AS3000 ANESTHESIA SYSTEM ANESTHESIA DELIVERY SYSTEM BSZ MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1