{ "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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INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. ENGINEERING EVALUATION COULD NOT VERIFY A SYSTEM MALFUNCTION. INVESTIGATION OF THE CASE LOGS SHOWED SOME INSTRUMENTS TOOK MULTIPLE ATTEMPTS TO VERIFY; HOWEVER, LOGS DID SHOW ALL INSTRUMENTS PASS VERIFICATION WITHIN THIS CASE. ULTIMATELY, THE USER WAS UNABLE TO RESOLVE THE ISSUES WITHIN THIS CASE AND THE PROCEDURE WAS ABORTED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. THE OBSERVED OVERALL RISK LEVEL IS LOW WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL. THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AND THERE IS NO FURTHER INVESTIGATION REQUIRED. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE." }, { "mdr_text_key": "362157063", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "HAD TO SHUT OFF 7 TIMES THROUGH OUT CASE TO EITHER GET IT TO SHOW US INSTRUMENTS THAT HAD ALREADY BEEN CHECKED IN BUT WAS SAYING THEY HAD NOT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "2560 GENERAL ARMISTEAD AVENUE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "19403", "manufacturer_contact_exchange": "610", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }