{ "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": "2026-07-28", "results": { "skip": 0, "limit": 1, "total": 1 } }, "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": "1001 MURRY RIDGE LANE", "manufacturer_contact_pcity": "72473302", "event_type": "Malfunction", "report_number": "2518422-2026-027787", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260630", "manufacturer_address_2": "", "pma_pmn_number": "K102465", "date_of_event": "20260603", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "505", "manufacturer_contact_plocal": "7247330200", "noe_summarized": "1", "manufacturer_contact_l_name": "ROSKO", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "PA", "reporter_country_code": "US", "manufacturer_contact_area_code": "724", "date_added": "20260630", "manufacturer_contact_f_name": "MELISSA", "device_date_of_manufacturer": "20140718", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "205504", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "Y", "date_received": "20260630", "brand_name": "BIPAP S/T C SERIES", "generic_name": "VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING", "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": "1060P", "catalog_number": "1060P", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MNS", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "00606959039155", "udi_public": "(01)00606959039155", "openfda": { "device_name": "Ventilator, Continuous, Non-Life-Supporting", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5895", "device_class": "2" } } ], "product_problems": [ "Degraded" ], "reporter_state_code": "WV", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260630", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7247", "patient": [ { "patient_sequence_number": "1", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260630", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MURRYSVILLE", "mdr_report_key": "25662223", "removal_correction_number": "Z-1974-2021", "number_devices_in_event": "", "date_manufacturer_received": "20260603", "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": "407399542", "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 THE C 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¿ ER 2205744 V11(YODA RISK MATRIX) WAS UPDATED TO INCLUDE HAZARDS ASSOCIATED WITH FOAM DEGRADATION BASED ON COMPLAINTS ANALYZED THROUGH VARIOUS HEALTH HAZARD EVALUATIONS (HHES). RISK TAGS ¿ VDURI005, VDTOX001 REFLECT 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. THE DEVICE MENTIONED IN THIS COMPLAINT HAS EXCEEDED ITS USEFUL LIFE PER THE APPLICABLE IFU." }, { "mdr_text_key": "407399543", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A BIPAP S/T C SERIES WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED ERROR CODES, THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSE THE REPORTED EVENT. IT WAS OBSERVED THAT SOME PORT COVERS OR ACCESSORY DOORS WERE MISSING. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1001 MURRY RIDGE LANE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "724", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }