BEUDAMED
    FDA Adverse Event Other Summary report: N

    GF-210RA

    MDR report key: 5648993 · Received May 11, 2016

    Report

    Report Number
    2032233-2016-00369
    Event Type
    Other
    Date Received
    May 11, 2016
    Date of Event
    June 29, 2016
    Report Date
    July 29, 2016
    Manufacturer
    NIHON KOHDEN TOMIOKA CORPORATION
    Product Code
    CCK
    UDI-DI
    04931921106891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTS THAT THE READINGS ON THE MULTI-GAS UNIT ARE NOT CORRECT AND ARE READING LOW. CUSTOMER HAS SENT THE DEVICE IN FOR EVALUATION AND REPAIR. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTS THAT THE READINGS ON THE MULTI-GAS UNIT ARE NOT CORRECT AND ARE READING LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304403 GF-210RA MULTI-GAS UNIT CCK NIHON KOHDEN TOMIOKA CORPORATION GF-210RA NA 04931921106891

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown