{ "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": "2026-06-30", "results": { "skip": 0, "limit": 1, "total": 31 } }, "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": "10520509", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200911", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200819", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "report_date": "20200902", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "", "manufacturer_contact_area_code": "", "date_added": "20200911", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "984017", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200911", "brand_name": "PHILIPS RESPIRONICS V60 VENTILATOR", "generic_name": "VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY", "manufacturer_d_name": "RESPIRONICS CALIFORNIA, LLC", "manufacturer_d_address_1": "2271 COSMOS CT", "manufacturer_d_address_2": "", "manufacturer_d_city": "CARLSBAD", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92011", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92011", "device_operator": "I", "model_number": "V60", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "MNT", "device_age_text": "7 YR", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Sv70 Ventilator", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5895", "device_class": "2" } } ], "product_problems": [ "Nonstandard Device", "Nonstandard Device" ], "reporter_state_code": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20200911", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20200824", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "date_report_to_manufacturer": "20200911", "manufacturer_contact_city": "", "mdr_report_key": "10520509", "removal_correction_number": "", "number_devices_in_event": "", "date_report_to_fda": "20200902", "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": "206519902", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON MARCH 2020, WE RECEIVED RECALL LETTER ENTITLED \"PHILIPS V60 VENTILATORS MAY SHUT DOWN UNEXPECTEDLY DUE TO A PREMATURE COMPONENT FAILURE.\" WE NOTIFIED PHILIPS THAT WE HAD FOUR AFFECTED V60 VENTILATORS THAT REQUIRED REPLACEMENT OF THE POWER MANAGEMENT PCBA PART. IN APRIL, PHILIPS SEND A SECOND LETTER IN REGARDS TO THE \"PHILIPS V60 VENTILATORS MAY SHUT DOWN UNEXPECTEDLY DUE TO A PREMATURE COMPONENT FAILURE\" INFORMING US THAT DUE TO COVID-19 THEY ARE EXPERIENCING A DELAY IN THE PRODUCTION OF THE COMPONENTS NECESSARY TO CORRECT/REPAIR THE VENTILATORS. THIS FACILITY DID NOT REMOVE ANY OF THE FOUR DEVICES FROM SERVICE PER PHILIPS ORIGINAL ANALYSIS THAT CONCLUDED IT IS NOT NECESSARY TO REMOVE AFFECTED PHILIPS V60S FROM SERVICE DUE TO THE RARITY OF THE FAILURE. PHILIPS MAINTAINED THAT THE PUBLIC HEALTH IS BEST PROTECTED BY LEAVING NON-FAILED V60S IN THE FIELD FOR CRITICAL LIFT-SUSTAINING THERAPEUTIC USE. BIOMED FOLLOW UP: BIOMED REQUESTED A SERVICE PERSON TO COME TO FACILITY AND REPAIR THIS VENT. PHILIPS HAS INDICATED THAT THEY WILL REMEDIATE THE RECALL ON THE VENT AT THAT TIME. PHILIPS EXPLAINED THAT THEY DO NOT HAVE THE INVENTORY OF PARTS TO REMEDIATE ALL OF OUR VENTS AFFECTED, BUT BECAUSE THIS ONE FAILED RELATIVE TO THE RECALL, THEY WILL REPAIR IT." } ], "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": "" } ] }