BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GF-210RA

    MDR report key: 6108359 · Received November 16, 2016

    Report

    Report Number
    8030229-2016-00540
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 17, 2016
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    CCK
    UDI-DI
    04931921106891
    PMA / PMN Number
    K110594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: THE CUSTOMER REPORTS THAT THE MULTI GAS UNIT CONSTANTLY GIVES A "CHECK WATER TRAP" ALARM. THE CUSTOMER HAS CHANGED THE WATER TRAP, HOWEVER AFTER 5-10 SECONDS, THE UNIT STILL ALARMS. CUSTOMER HAS SENT THE DEVICE IN FOR EVALUATION AND REPAIR. THE DEVICE RELATED TO THIS COMPLAINT WAS RETURNED AND EVALUATED. NO MALFUNCTION WAS FOUND. THE DEVICE WAS RETURNED TO CUSTOMER WITHOUT BEING REPAIRED. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR PART 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTS THAT THE MULTI GAS UNIT CONSTANTLY GIVES A "CHECK WATER TRAP" ALARM. THE CUSTOMER HAS CHANGED THE WATER TRAP, HOWEVER AFTER 5-10 SECONDS, THE UNIT STILL ALARMS. 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 CUSTOMER REPORTS THAT THE MULTI GAS UNIT CONSTANTLY GIVES A "CHECK WATER TRAP" ALARM. THE CUSTOMER HAS CHANGED THE WATER TRAP, HOWEVER AFTER 5-10 SECONDS, THE UNIT STILL ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758659 GF-210RA MULTI-GAS UNIT CCK NIHON KOHDEN CORPORATION GF-210RA 04931921106891

    Patients

    Seq Age Sex Outcome Treatment
    1