MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO; GENERATOR, OXYGEN, PORTABLE

Model Number	1020010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adult Respiratory Distress Syndrome (1696); Dyspnea (1816); Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information from the reporter (patient's son and caregiver) alleging that due to a malfunction (unspecified) of the device (everflo oxygen concentrator), the patient experienced an adverse event prompting emergency medical services (ems) to be contacted.The reporter (patient's son) contacted ems at 0605 local time on the date of event due to the patient's increasing shortness of breath.The reporter has alleged that the adverse event was due to an unspecified device malfunction.Ems was reported to have arrived at the patient's location (home) at 0620 local time.Patient evaluation was conducted on arrival with vitals reported as: spo2 48% with the patient breathing room air (device not connected to patient), respiratory rate 36, heart rate 105, blood pressure 127/70.Patient assessment found the patient in severe respiratory distress, tachypneic, hypoxic, and tachycardic.It was unclear why the patient was not using the device in question at the time of assessment, nor was it clear if the patient increased shortness of breath occurred while using the device.The patient wasn't able to provide further elaboration.Glasgow coma scale was conducted with reported value of 15.Ems applied 4 l/min supplemental oxygen via nasal cannula to the patient with noted improvement of the patient's spo2.Additional treatments included salbutamol x8 mdi with noted efficacy, atrovent x2 mdi with noted efficacy, dexamethasone 8 mg orally with noted improvement.Vitals fluctuated throughout the duration of treatment and transport (0620-0710 local time) with recorded values ranging from spo2 84-93% gradually improving over time on 3 l/min via nasal cannula, respiratory rate decreased from 36 to 20 breathes per minute, heart rate decrease from 105 to 98, blood pressure 127/70 with decrease to 116/70.The patient was transferred to an institutional medical facility with arrival at 0710 local time.Final assessment by ems reported the reason for transfer as exacerbation of copd with improved response.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously information from the reporter (patient's son and caregiver) alleging that due to a malfunction (unspecified) of the device (everflo oxygen concentrator), the patient experienced an adverse event prompting emergency medical services (ems) to be contacted.The reporter (patient's son) contacted ems at 0605 local time on the date of event due to the patient's increasing shortness of breath.The reporter has alleged that the adverse event was due to an unspecified device malfunction.Ems was reported to have arrived at the patient's location (home) at 0620 local time.Patient evaluation was conducted on arrival with vitals reported as: spo2 48% with the patient breathing room air (device not connected to patient), respiratory rate 36, heart rate 105, blood pressure 127/70.Patient assessment found the patient in severe respiratory distress, tachypneic, hypoxic, and tachycardic.It was unclear why the patient was not using the device in question at the time of assessment, nor was it clear if the patient increased shortness of breath occurred while using the device.The patient wasn't able to provide further elaboration.Glasgow coma scale was conducted with reported value of 15.Ems applied 4 l/min supplemental oxygen via nasal cannula to the patient with noted improvement of the patient's spo2.Additional treatments included salbutamol x8 mdi with noted efficacy, atrovent x2 mdi with noted efficacy, dexamethasone 8 mg orally with noted improvement.Vitals fluctuated throughout the duration of treatment and transport (0620-0710 local time) with recorded values ranging from spo2 84-93% gradually improving over time on 3 l/min via nasal cannula, respiratory rate decreased from 36 to 20 breathes per minute, heart rate decrease from 105 to 98, blood pressure 127/70 with decrease to 116/70.The patient was transferred to an institutional medical facility with arrival at 0710 local time.Final assessment by ems reported the reason for transfer as exacerbation of copd with improved response.Multiple good-faith efforts were made to retrieve the device, but they were unsuccessful.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.

• Brand Name: EVERFLO
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 23774873
• Report Number: 2518422-2025-112551
• Device Sequence Number: 15972375
• Product Code: CAW
• UDI-Device Identifier: 00606959001077
• UDI-Public: (01)00606959001077
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1020010
• Device Catalogue Number: 1020010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown