{ "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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IT WAS CONCLUDED THAT THE REFLECTOR PRESSURE TRANSDUCER PC BOARD WAS FAULTY AND NEEDED TO BE REPLACED. AFTER REPLACEMENT, THE DEVICE WAS SUCCESSFULLY TESTED AND RETURNED TO CLINICAL USE. NO REPORTS OF ISSUES HAVE BEEN RECEIVED EVER SINCE. THE RECEIVED LOGS CONFIRM THE REPORTED ISSUE WITH LEAKAGE DURING SCO AND ALSO A DRIFTING REFLECTOR PRESSURE TRANSDUCER CAUSING PRESSURE TRANSDUCER TESTS TO FAIL. THE REPLACED PART WAS RETURNED AND VISUALLY EXAMINED. NO DEVIATIONS COULD BE SEEN. SEVERAL SUCCESSFUL SCO: S WERE PERFORMED. SIMULATED USE TESTING DURING ONE WEEK IN A REFERENCE MACHINE WAS PERFORMED WITHOUT ANY ISSUES. AFTER THE VENTILATION PERIOD, ADDITIONAL SUCCESSFUL SCO: S WERE PERFORMED. THE REPORTED ISSUE COULD NOT BE REPRODUCED. NO DRIFT OF THE ZERO PRESSURE OFFSET COULD BE NOTICED. BASED ON THE RECEIVED LOGS FROM THE EVENT, THE REFLECTOR ZERO PRESSURE OFFSET OF THE PRESSURE TRANSDUCER HAD DRIFTED AND THAT WAS THE CAUSE OF THE REPORTED ISSUE." }, { "mdr_text_key": "323271439", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "MANUFACTURER'S (B)(4)." }, { "mdr_text_key": "320665406", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "MANUFACTURER'S (B)(4)." }, { "mdr_text_key": "320665407", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ANESTHESIA WORKSTATION WAS INVESTIGATED BY OUR COMPANY FIELD SERVICE ENGINEER. IT WAS CONCLUDED THAT THE REFLECTOR PRESSURE TRANSDUCER PC BOARD WAS FAULTY AND NEEDED TO BE REPLACED. AFTER REPLACEMENT, THE THE DEVICE WAS SUCCESSFULLY TESTED AND RETURNED TO CLINICAL USE. NO REPORTS OF ISSUES HAVE BEEN RECEIVED EVER SINCE. THE REPLACED PART HAS NOT BEEN RETURNED FOR INVESTIGATION. THE RECEIVED LOGS CONFIRM THE REPORTED ISSUE WITH LEAKAGE DURING SCO AND ALSO A DRIFTING REFLECTOR PRESSRE TRANSDUCER CAUSING PRESSURE TRANSDUCER TESTS TO FAIL. BASED ON THE RECEIVED INFORMATION, LOGS, THE MOST LIKELY CAUSE OF THE REPORTED EVENT ISA DRIFTING ZERO PRESSURE OFFSET OF THE REFLECTOR PRESSRE TRANSDUCER. AS THE REPLACED PART HAS NOT BEEN RETURNED FOR INVESTIGATION, WE HAVE NOT BEEN ABLE TO DETERMINE WHY THE REFLECTOR ZERO PRESSURE OFFSET OF THE PRESSURE TRANSDUCER´S HAD DRIFTED." }, { "mdr_text_key": "189056405", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION FAILED THE PRESSURE TRANSDUCER TEST AND THE AUTOMATIC VENTILATION LEAKAGE TEST DURING SYSTEM CHECK OUT. THERE WAS NO PATIENT CONNECTED TO THE WORKSTATION AT THE TIME OF THE EVENT. MANUFACTURER´S REF #: (B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/16/2020;02/24/2021" } ] }