CAP-ONE

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE AIRWAY ADAPTERS APPEARED CLOUDY AND GAVE INACCURATE READINGS. NO PATIENT HARM WAS REPORTED. ONE ADAPTER DISPLAYED AN ETCO2 VALUE OF 52, WHICH SEEMED UNUSUALLY HIGH FOR A PATIENT WITHOUT LUNG DISEASE WHO WAS FULLY SUPPORTED WITH APPROPRIATE TIDAL VOLUME AND RESPIRATORY RATE. A SECOND NK ADAPTER PRODUCED A SIMILAR RESULT, WHILE THE VENTILATOR MODULE SHOWED ETCO2 READINGS OF 38-40. CLINICAL STAFF NOTED THAT ADAPTERS FROM LOT NUMBERS BEGINNING WITH 309 APPEARED TO PERFORM BETTER THAN THOSE BEGINNING WITH 507. THE AFFECTED LOT NUMBER WAS #50917ACC. THE ADAPTER WAS REPLACED TWICE USING THE SAME G7 MONITOR (CU-172RA, SN: (B)(6) AND CAP ONE CABLE TG-980. THE BME WAS UNSURE IF THE RESPIRATORY TEAM HAD RECALIBRATED / RE-ZEROED OUT THE MONITOR. 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 DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CO2 AIRWAY ADAPTER: G7 MONITOR (G7): MODEL #: CU-172RA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 10/25/2024. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NOT RETURNED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE AIRWAY ADAPTERS APPEARED CLOUDY AND GAVE INACCURATE READINGS. NO PATIENT HARM WAS REPORTED.