BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GF-210RA

    MDR report key: 4488116 · Received February 2, 2015

    Report

    Report Number
    2080783-2015-00012
    Event Type
    Malfunction
    Date Received
    February 2, 2015
    Date of Event
    January 5, 2015
    Report Date
    January 5, 2015
    Manufacturer
    NIHON KOHDEN CORP
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE GF-210RA MULTI-GAS UNIT USED FOR MEASUREMENT OF ANESTHETIC GAS AGENTS, OXYGEN, OR CO2 DISPLAYS A CHECK WATER TRAP ERROR EVEN WHEN A BRAND NEW WATER TRAP IS BEING USED. MFR 8030209-2015-00012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76111 GF-210RA MULTI-GAS UNIT CCK NIHON KOHDEN CORP GF-210RA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI