{ "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": "2026-09-29", "results": { "skip": 0, "limit": 1, "total": 23685 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "PA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MURRYSVILLE", "manufacturer_contact_address_1": "6501 LIVING PLACE", "manufacturer_contact_pcity": "41254233", "event_type": "Malfunction", "report_number": "2518422-2026-018508", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260603", "manufacturer_address_2": "", "pma_pmn_number": "K131982", "date_of_event": "20260515", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4125423300", "noe_summarized": "1", "manufacturer_contact_l_name": "ROSKO", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "PA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260603", "manufacturer_contact_f_name": "MELISSA", "device_date_of_manufacturer": "20180802", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1433503", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20260603", "brand_name": "DREAMSTATION", "generic_name": "VENTILATOR, NON-CONTINUOUS (RESPIRATOR)", "manufacturer_d_name": "RESPIRONICS, INC.", "manufacturer_d_address_1": "1001 MURRY RIDGE LANE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MURRYSVILLE", "manufacturer_d_state": "PA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "OTHER", "model_number": "DSX500H11C", "catalog_number": "DSX500H11C", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "BZD", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "00606959051515", "udi_public": "(01)00606959051515", "openfda": { "device_name": "Ventilator, Non-Continuous (Respirator)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5905", "device_class": "2" } } ], "product_problems": [ "Degraded" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260702", "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": "20260603", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260603", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "PITTSBURGH", "mdr_report_key": "25369283", "removal_correction_number": "Z-1974-2021", "number_devices_in_event": "", "date_manufacturer_received": "20260515", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Recall" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "RESPIRONICS, INC.", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "403461399", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A DREAMSTATION AUTO CPAP DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF VISIBLE FOAM PARTICLES WERE FOUND. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DUST FAIL AND DESTROYED POWER CONNECTOR. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED." }, { "mdr_text_key": "403461400", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE AFFECTED PRODUCTS WITH FIELD COMPLAINTS ALLEGING PE-PUR FOAM DEGRADATION HAVE UNDERGONE THE ESTABLISHMENT OF COMPLAINT CODES SPECIFICALLY IDENTIFYING FOAM DEGRADATION, FOR DREAM STATION CPAP/BIPAP SERIES. A FIELD CORRECTION ACTION(2021-06-A) WAS INITIATED, AND MEDICAL DEVICE RECALL LETTERS WERE ISSUED. A FIELD ACTION WAS INITIATED TO REPLACE PE-PUR FOAM IN AFFECTED PRODUCTS; DEGRADATION WAS ADDED TO THE RESPECTIVE DFMEAS AND THE RISK MANAGEMENT FILE THAT WAS CURRENT AT THE TIME ¿ ER 2219697 V15 (NIRVANA RISK MANAGEMENT MATRIX) WAS UPDATED TO INCLUDE HAZARDS ASSOCIATED WITH FOAM DEGRADATION BASED ON COMPLAINTS ANALYZED THROUGH VARIOUS HEALTH HAZARD EVALUATIONS (HHES). RISK TAGS ¿ DEGRAD04, IRRIT05 REFLECTED THE SAFETY RISK ASSESSMENT OF DESIGN CONTAINING THE AFFECTED PE-PUR FOAM. THESE COMPLAINTS WERE MONITORED AND TRENDED IN ACCORDANCE WITH THE COMPLAINT TRENDING PROCEDURES. IF THE COMPLAINTS WERE DETERMINED TO MEET THE CRITERIA FOR ESCALATION, THEY WERE ESCALATED FOR RISK ASSESSMENT THROUGH THE POST MARKET CLINICAL ESCALATION PROCESS. AS OF THE DATE OF SUBMISSION FOR THIS REPORT, THERE IS NO INDICATION THAT COMPLAINTS FOR THE FAILURE IN QUESTION HAVE LED TO UNACCEPTABLE LEVELS OF SEVERITY OR PROBABILITIES OF HARM, AND THEREFORE NO FURTHER ACTION WILL BE PURSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1001 MURRY RIDGE LANE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }