{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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"THE CUSTOMER REPORTED THAT THE MULTIGAS UNIT WAS NOT DISPLAYING CO2 READINGS." }, { "mdr_text_key": "330560365", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE MULTIGAS UNIT WAS NOT DISPLAYING CO2 READINGS. NO ERROR MESSAGES WERE GENERATED. NO PATIENT HARM OR INJURY WAS REPORTED. THE CUSTOMER SENT THE UNIT IN FOR A REPAIR. SERVICE REQUESTED / PERFORMED: EVALUATION / REPAIR. INVESTIGATION SUMMARY: THE INVESTIGATION CONDUCTED UNDER IRC-NKA300155492 (ATTACHED A3-191237_FINAL-EG.PDF) CONCLUDED THAT FOR GF-210RA REVISION CB AND ONWARD WITH SENSOR UNIT CD-314P REVISION 2 (SERIAL NUMBERS (B)(6) NEEDED A FIRMWARE UPGRADE. REVISION 2 OF CD-314P UTILIZE A NEW PUMP WITH A SLIGHT DIFFERENCE IN SPECIFICATION. THE SENSOR UNIT DETECTS THIS SMALL DIFFERENCE AND OUTPUT AS GAS DEVICE ERROR. THE COUNTERMEASURE IS TO PERFORM A FIRMWARE UPGRADE. THE CAUSES FOR GAS DEVICE ERROR ARE DUE TO IMPROPER MAINTENANCE, INCOMPATIBLE TUBING/CONNECTOR, DEVICE DAMAGE, OR SENSOR NEEDING REPLACEMENT. FURTHER ACTION IS NOT WARRANTED." }, { "mdr_text_key": "200651441", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE CUSTOMER REPORTED THAT THE MULTIGAS UNIT IS NOT DISPLAYING ANY CO2 READINGS. NO ERRORS GENERATED. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER WILL BE SENDING THIS UNIT IN FOR A 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." }, { "mdr_text_key": "200651442", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CUSTOMER REPORTED THAT THE MULTIGAS UNIT IS NOT DISPLAYING ANY CO2 READINGS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "ATTN: SHAMA MOOMAN", "distributor_zip_code": "", "manufacturer_contact_postal_code": "359-8580", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/14/2022" } ] }