BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GF-210RA

    MDR report key: 13057800 · Received December 21, 2021

    Report

    Report Number
    8030229-2021-02220
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    November 24, 2021
    Report Date
    March 31, 2023
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    CCK
    UDI-DI
    04931921106891
    PMA / PMN Number
    K110594
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIGAS UNIT WAS GIVING INTERMITTENT GAS READINGS. THIS WAS HAPPENING OFTEN DURING CASES. THE ISSUE COULD USUALLY BE CORRECTED BY POWERING DOWN, UNPLUGGING, RECONNECTING, AND POWERING BACK ON THE UNIT. THE UNIT WAS SENT IN FOR AN EXCHANGE. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE MULTIGAS UNIT'S SN IS LOWER THAN (B)(6) AND HAD A DIFFERENT DESIGN FROM THE NEWER UNITS THAT START AT SN (B)(6). AS SUCH, THE UNIT COULD NOT BE REPAIRED. THE DEVICE NEEDED THE GAS SENSOR, (PART # CD-314P) TO BE REPLACED. THE GAS SENSOR IS A REPLACEABLE COMPONENT, WHERE THE LONGEVITY IS DEPENDENT UPON THE FOLLOWING FACTORS: · INSTRUMENT AND PARTS MUST UNDERGO REGULAR MAINTENANCE INSPECTION AT LEAST EVERY 6 MONTHS. · IF STORED FOR EXTENDED PERIODS WITHOUT BEING USED, MAKE SURE PRIOR TO OPERATION THAT THE INSTRUMENT IS IN PERFECT OPERATING CONDITION. · WATER TRAP SHOULD BE REPLACED EVERY 4 WEEKS OR AS INDICATED ON THE DEVICE. · ENSURING THE ENVIRONMENT IS OPTIMAL AS DESCRIBED IN THE OPERATOR'S MANUAL. AS INDICATED UNDER TICKET 127139, THERE IS NO OTHER EVIDENCE SUGGESTING PREDISPOSITION TO EARLY FAILURE. THE LIKELY CAUSE IS A LACK OF ON-TIME PREVENTATIVE MAINTENANCE. DUE TO LIMITED INFORMATION AVAILABLE REGARDING ROUTINE MAINTENANCE, THE ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT? D9 DEVICE AVAILABLE FOR EVALUATION? G3 DATE RECEIVED BY MANUFACTURER? G6 TYPE OF REPORT? H2 IF FOLLOW-UP, WHAT TYPE? H3 DEVICE EVALUATED BY MANUFACTURER? H6 EVENT PROBLEM AND EVALUATION CODES?

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THEY ARE GETTING INTERMITTENT GAS READINGS ON THIS MULTIGAS UNIT. THIS HAPPENS VERY OFTEN AND THAT THEY CAN USUALLY CORRECT IT BY POWERING DOWN, UNPLUGGING, RECONNECTING, AND POWERING BACK ON. HOWEVER, THIS SEEMS TO HAPPEN ALL THE TIME, ESPECIALLY DURING LIVE CASES, AND THE CUSTOMER IS LOOKING FOR OPTIONS TO RESOLVE THIS ISSUE. THE UNIT IS BEING EXCHANGED. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIGAS UNIT WAS GIVING INTERMITTENT GAS READINGS. THIS WAS HAPPENING OFTEN DURING CASES. THE ISSUE COULD USUALLY BE CORRECTED BY POWERING DOWN, UNPLUGGING, RECONNECTING, AND POWERING BACK ON THE UNIT. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951391 GF-210RA MULTI-GAS UNIT CCK NIHON KOHDEN CORPORATION GF-210RA NA 04931921106891

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BEDSIDE MONITOR| BEDSIDE MONITOR