BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANESTHESIA MACHINE

    MDR report key: 1659102 · Received April 12, 2010

    Report

    Report Number
    2221819-2010-00012
    Event Type
    Malfunction
    Date Received
    April 12, 2010
    Date of Event
    April 2, 2010
    Report Date
    April 5, 2010
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY DS USA, INC. IDENTIFIED AN ISSUE WITH THE DIE CAST OF THE ALUMINUM CASTER MOUNT. WE HAVE INITIATED A FIELD CORRECTION TO REPLACE THE AFFECTED CASTER MOUNTS. FDA'S (B) (4) OFFICE HAS BEEN NOTIFIED. THEY HAVE NOT YET ADVISED US OF THE IDENTIFICATION NUMBER ASSOCIATED WITH THIS FIELD CORRECTION. THE CUSTOMER WAS ADVISED OF THE ACTION VIA CUSTOMER NOTIFICATION LETTER DATED MARCH 5, 2010. ALL OF THEIR AS3000'S WERE UPGRADED FOR THE FIELD CORRECTION ON APRIL 5, 2010.

    Description of Event or Problem · 1

    THE CUSTOMER ADVISED A MINDRAY CLINICAL REPRESENTATIVE THAT WHILE MOVING AN AS3000 ANESTHESIA MACHINE BETWEEN ROOMS AT THE HOSPITAL, A CASTER MOUNT BROKE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANESTHESIA MACHINE ANESTHESIA MACHINE BSZ MINDRAY DS USA, INC. AS3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK