BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AG-920RA

    MDR report key: 4949350 · Received July 27, 2015

    Report

    Report Number
    2080783-2015-00185
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    June 30, 2015
    Report Date
    June 30, 2015
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE AG-920PA MULTI-GAS UNIT (USED FOR MEASUREMENT OF ANESTHETIC GAS AGENTS, OXYGEN, OR CO2) REPORTED A CALIBRATION ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485554 AG-920RA MULTI-GAS UNIT CCK NIHON KOHDEN CORP. AG-920RA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI