BEUDAMED
    FDA Adverse Event Other Summary report: N

    AS3000

    MDR report key: 1613702 · Received January 29, 2010

    Report

    Report Number
    2221819-2010-00004
    Event Type
    Other
    Date Received
    January 29, 2010
    Date of Event
    January 4, 2010
    Report Date
    January 4, 2010
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE REPLACED THE CASTER MOUNT AND WHEEL. HE INSPECTED THE OTHER AS3000'S AT THE FACILITY AND DID NOT FIND ANY VISIBLE DEFECTS. THIS INCIDENT IS UNDER INVESTIGATION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER ADVISED A COMPANY SERVICE REPRESENTATIVE THAT WHILE THE AS3000 ANESTHESIA SYSTEM WAS BEING MOVED FROM ONE ROOM TO ANOTHER, THE FRONT CASTER MOUNT BROKE, THE CASTER CAME OFF, AND THE SYSTEM FELL. TWO HOSPITAL EMPLOYEES WERE INJURED WHEN THE SYSTEM FELL - ONE HAD A BACK INJURY, AND ONE HAD ARM, BACK, AND NECK INJURIES. BOTH EMPLOYEES WERE TREATED IN THE EMERGENCY ROOM AND RELEASED.

    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 UNK Hospitalization