BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AG-920RA

    MDR report key: 9300115 · Received November 8, 2019

    Report

    Report Number
    8030229-2019-00637
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 16, 2019
    Report Date
    September 27, 2021
    Product Code
    CCK
    UDI-DI
    00841983103162
    PMA / PMN Number
    K020046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT GAVE INACCURATE CO2 READINGS. THE CUSTOMER INDICATED THAT THIS UNIT WOULD WORK AND GAVE ACCURATE READINGS FOR ABOUT 30 MINUTES, BUT THEN THE CO2 READINGS WOULD START TO GET ERRATIC AND INCORRECT. HE REPLACED THE SAMPLING LINE AND WATER TRAP ON THE UNIT, BUT IT STILL GAVE INCORRECT READINGS. THE CUSTOMER THEN TRIED TO CALIBRATE THE UNIT, BUT THE DEVICE DISPLAYED A "CAL ERROR" MESSAGE, AND HE WAS UNABLE TO SUCCESSFULLY CALIBRATE THE GAS UNIT. THE CUSTOMER SENT THE UNIT IN FOR EVALUATION. NO PATIENT HARM WAS REPORTED. SERVICE REQUESTED / PERFORMED: EVALUATION / REPAIR: ON 12/23/2019, THE UNIT WAS CLEANED AND DECONTAMINATED BY NIHON KOHDEN AMERICA REPAIR CENTER (NKA RC). NO PHYSICAL DAMAGE WAS NOTICED. ON RC EVALUATION, THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE UNIT OPERATED WELL, ALTHOUGH, THERE WAS A CONSTANT LOUD HUMMING NOISE WHICH INDICATED THAT THE GAS MODULE WOULD DETERIORATE SOON. ON 01/27/2020, THE FOLLOWING MALFUNCTIONING PART WAS REPLACED AS A PRECAUTIONARY MEASURE, (# CD-237P; GAS MODULE). THE UNIT WAS TESTED PER THE OPERATOR'S/SERVICE MANUAL AND THE RESULTS WERE RECORDED ON THE MAINTENANCE CHECK SHEET. THE UNIT COMPLETED 24 HOURS OF EXTENDED TESTING AND OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. THE REPAIRED UNIT WAS SHIPPED TO THE CUSTOMER ON (B)(6)2020. INVESTIGATION SUMMARY: THE OVERALL RISK OF THIS EVENT IS DETERMINED TO BE MEDIUM. PER THE OPERATOR'S MANUAL, THE POSSIBLE CAUSES OF THE UNIT DISPLAYING THE "CAL ERROR" MESSAGE ARE ISSUES WITH WATER TRAP, SAMPLING LINE, T-PIECE OR EXHAUST TUBE WHICH NEED TO BE REPLACED, IF NECESSARY. IT COULD ALSO BE CAUSED IF INCORRECT GAS WAS BEING USED FOR CALIBRATION. THE REPORTED ISSUE DOES NOT REQUIRE FURTHER INVESTIGATION THROUGH CAPA PROCESS SINCE THE AG-920RA IS A LEGACY PRODUCT AND SALES FOR THE UNIT ENDED IN 2013. ALSO, NKA RC COULD NOT REPLICATED THE ISSUE ON EVALUATION, HENCE NO ROOT CAUSE COULD BE ATTRIBUTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT GAVE INACCURATE CO2 READINGS. NO PATIENT HARM REPORTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE MULTI-GAS UNIT GAVE INACCURATE CO2 READINGS. NO PATIENT HARM REPORTED. THE CUSTOMER INDICATED THAT THIS UNIT WOULD WORK AND GAVE ACCURATE READINGS FOR ABOUT 30 MINUTES, BUT THEN THE CO2 READINGS WOULD START TO GET ERRATIC AND INCORRECT. HE REPLACED THE SAMPLING LINE AND WATER TRAP ON THE UNIT, BUT IT STILL GAVE INCORRECT READINGS. THE CUSTOMER THEN TRIED TO CALIBRATE THE UNIT, BUT THE DEVICE DISPLAYED A "CAL ERROR" AND HE WAS UNABLE TO SUCCESSFULLY CALIBRATE THE GAS UNIT. THE CUSTOMER SENT THE UNIT IN AND IT IS CURRENTLY AWAITING EVALUATION. 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 REPORTED THAT THE MULTI-GAS UNIT GAVE INACCURATE CO2 READINGS. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093928 AG-920RA MULTI-GAS UNIT CCK AG-920RA NA 00841983103162

    Patients

    Seq Age Sex Outcome Treatment
    1