{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-11", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "Y", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "6728536", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20170720", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20160701", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "report_date": "20170711", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20170720", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "509359", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170720", "brand_name": "PHILIPS INTELLIVUE MX450 PATIENT MONITOR", "generic_name": "PATIENT PHYSIOLOGICAL MONITOR", "manufacturer_d_name": "PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH", "manufacturer_d_address_1": "3000 MINUTEMAN ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "ANDOVER", "manufacturer_d_state": "MA", "manufacturer_d_zip_code": "01810", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "01810", "device_operator": "NURSE", "model_number": "866062", "catalog_number": "866062", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "MHX", "device_age_text": "1 YR", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ], "product_problems": [ "Device Alarm System", "Improper or Incorrect Procedure or Method", "Component Missing" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250817", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20170720", "sequence_number_treatment": [ "THE PHILIPS MX-800 AND MX-450 ARE USE IN THE ICU A" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20170711", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "date_report_to_manufacturer": "20170711", "manufacturer_contact_city": "", "mdr_report_key": "6728536", "removal_correction_number": "", "number_devices_in_event": "", "date_report_to_fda": "20170711", "manufacturer_name": "", "report_source_code": "User Facility report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "80564306", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "EKG WAVEFORM IS DISAPPEARING FROM THE SCREEN WHILE PATIENTS ARE CONNECTED TO THE PHYSIOLOGICAL MONITORS. CURRENTLY WE USE PHILIPS MX-800 AND MX-450 IN THE INTENSIVE CARE UNIT AND EMERGENCY DEPARTMENT AREAS WHERE THE PROBLEMS HAVE BEEN NOTICED. WE ARE RUNNING SOFTWARE REVISION K IN ALL OUR MONITORS. THIS ISSUE HAS BEEN HAPPENING SINCE LAST YEAR. THE MONITORS ARE ABLE TO DISPLAY OTHER PHYSIOLOGICAL PARAMETERS WHILE THE ECG WAVEFORM IS MISSING FROM THE SCREEN. THE MONITORS ARE NOT DISPLAYING ANY ALARM OR MESSAGE. THE PROBLEM HAPPENS RANDOMLY. WE HAVE VIDEOS SHOWING THE ACTUAL PROBLEM. INITIALLY WE WERE UNDER THE IMPRESSION THAT THE PROBLEM WAS RELATED TO THE ECG LEADS OR ELECTRODES. HOWEVER, AFTER A YEAR OF PRETTY MUCH REPLACING ALL THE LEADS ON DOZENS OF MONITORS AND TRYING DIFFERENT ELECTRODES FROM DIFFERENT MANUFACTURES, WE BELIEVE THAT THE PROBLEM IS RELATED TO THE PHYSIOLOGICAL MONITORS. MANUFACTURER RESPONSE FOR PHYSIOLOGICAL MONITOR, MX800 AND MX450 (PER SITE REPORTER): THE MANUFACTURER IS AWARE OF IT. ACCORDING TO THEM THEY DON'T HAVE REPORTS FROM OTHER FACILITIES HAVING THIS PROBLEM. THEY HAVE BEEN RESPONSIVE. HOWEVER, THERE IS A LACK OF COMMUNICATION AND EXECUTION. THEY DON'T HAVE A SENSE OF URGENCY. AFTER, WE WANTED TO SHOW THEM THE VIDEOS OF THE PROBLEM THAT WE HAVE, THEY DIDN'T MAKE ANY ATTEMPT TO WATCH THE VIDEO. LAST WEEK, A PHILIPS FIELD SERVICE ENGINEER CAME ON-SITE TO UPLOAD A NEW CONFIGURATION ON SOME OF THE PHYSIOLOGICAL MONITORS THAT WE HAVE IN THE EMERGENCY DEPARTMENT. HOWEVER, SOME OF THE MONITORS THAT WERE UPDATED HAD TO BE ROLLBACK TO THE ORIGINAL CONFIGURATION BECAUSE HE DIDN'T INSTALL THE CORRECT FILE AND SOFTWARE REVISION." } ], "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": "" } ] }