BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS3000

    MDR report key: 1705521 · Received May 28, 2010

    Report

    Report Number
    2221819-2010-00019
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Date of Event
    May 21, 2010
    Report Date
    May 21, 2010
    Manufacturer
    MINDRAY DS USA, INC
    Product Code
    BSZ
    Removal / Correction Number
    Z-1313-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    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 OF THE FIELD CORRECTION (B) (4). THE DISTRIBUTOR WAS ADVISED OF THIS ACTION VIA CUSTOMER NOTIFICATION LETTER DATED MARCH 5, 2010. REPLACEMENT CASTER MOUNTS ARE BEING PROVIDED TO THE DISTRIBUTOR.

    Description of Event or Problem · 1

    MINDRAY DS USA INC'S DISTRIBUTOR IN (B) (4) ADVISED A COMPANY REP THAT WHILE THE AS3000 ANESTHESIA SYSTEM WAS BEING SET UP FOR DISPLAY DURING THE ANESTHESIA CONGRESS AT THE (B) (4) HOTEL IN (B) (4), THE CASTER MOUNT BROKE, AND THE WHEEL CAME OFF THE UNIT. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA