{ "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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PRODUCT WAS RECEIVED IN HOUSE ON THE 27 MAY 2020 - CURRENTLY AWAITING INVESTIGATION RESULTS. CUSTOMER CONFIRMED NO PATIENT INVOLVEMENT." }, { "mdr_text_key": "195237969", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE PROBE IS GOOD BUT THERE IS NO HEART RATE DETECTION AND NO EVIDENCE OF THIS UNIT BEING DROPPED. CUSTOMER CONFIRMED NO PATIENT INVOLVEMENT. FAILURE FOUND WHEN NURSE WAS CHECKING THE EQUIPMENT." }, { "mdr_text_key": "315040357", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION AND FINDINGS REF COMPLAINT#: (B)(4). IT WAS CONFIRMED THE UNIT HAD NO SOUND DUE TO CORROSION ON THE CIRCUIT BOARD. THE CIRCUIT BOARD WAS REPLACED AND TESTED, THE UNIT PASSED ALL FUNCTIONAL TESTS.\" DIAGNOSTIC CODE LABELLED AS \"BROKEN/CRACKED\". RISK REVIEW: RISK ASSESSMENT STANDARD SPREADSHEET, HAZARD ID 5.32, EFFECT - CANNOT COMPLETE EXAM OR INCORRECT DIAGNOSIS, SEVERITY - 3, RESIDUAL RISK - 9, ACCEPTABLE. DEVICE HISTORY RECORD SHOWS UNIT HAD PASSED ALL THE REQUIRED TESTS. NO MANUFACTURING DEFECTS OR NON-CONFORMANCES WERE OBSERVED. SERVICE REPAIR INVESTIGATIONS WILL BE CONDUCTED DURING THE REPAIR PROCESS AND TREND DATA WILL BE REVIEWED PER (B)(4). PER (B)(4) COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED. NO FURTHER ACTIONS NECESSARY." }, { "mdr_text_key": "315040358", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE PROBE IS GOOD BUT THERE IS NO HEART RATE DETECTION AND NO EVIDENCE OF THIS UNIT BEING DROPPED. CUSTOMER CONFIRMED NO PATIENT INVOLVEMENT. FAILURE FOUND WHEN NURSE WAS CHECKING THE EQUIPMENT." } ], "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": "07/02/2020" } ] }