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

Model Number	1020010
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chronic Obstructive Pulmonary Disease (COPD) (2237); Insufficient Information (4580)
Date of Event	10/30/2025
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging that the patient's everflo device "appeared to deliver insufficient oxygen while failing to trigger any alarms or warnings" during which time the patient's oxygen saturation consistently averaged around 87% and he experienced a marked decline in cognitive and physical health which continued for several months before the device was replaced, at which point his oxygen saturations returned to "normal levels".The reporter stated that given these observations, they are "deeply concerned that the concentrator may have been operating below its intended oxygen concentration output without any indication of malfunction." the reporter stated that they have records of oxygen saturation readings, hospital and ambulance reports, and other documentation that clearly show the progressive impact this fault had on their father¿s health.The reporter stated that their late father was on the device for copd ¿ emphysema.The reporter stated that the oxygen concentrator is no longer available for return because it was destroyed.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported information in relation to a report alleging serious concern regarding the performance of an everflo device.This is a follow up report to correct the become aware date, the country of occurrence and to update the problem description (section b5).Please refer to the description below for reporting purposes.The manufacturer received additional information through a good faith effort attempt on 11/10/2025, that an event occurred in australia.This information was discovered when requesting device information.It was during this good faith effort attempt the manufacturer was made aware that the incident had occurred in australia on a everflo device.Since it is unclear which device the allegation of harm is against, this report is being sent to be filed under the (original device) sn (not confirmed) (everflo intl opi 230v australia).The second device will have all reporting done under sn ((b)(6)) material number (1020010) everflo intl opi 230v australia, pr (b)(4).The manufacturer received information alleging that the patient's (original) everflo device "appeared to deliver insufficient oxygen while failing to trigger any alarms or warnings" during which time the patient's oxygen saturation consistently averaged around 87% and he experienced a marked decline in cognitive and physical health which continued for several months before the device was replaced, at which point his oxygen saturations returned to "normal levels".The original device has been reported to be in continuous home use from november 2017 until march 2023.The reporter stated that given these observations, they are "deeply concerned that the concentrator may have been operating below its intended oxygen concentration output without any indication of malfunction." the reporter stated that they have records of oxygen saturation readings, hospital and ambulance reports, and other documentation that clearly show the progressive impact this fault had on their father¿s health.The reporter stated that their late father was on the device for copd ¿ emphysema.The reporter stated that the oxygen concentrator is no longer available for return because it was destroyed.The patient's son reports the device went without maintenance which may have been the primary cause of the patient's chest infection and sudden death especially considering they were doing quite well in the weeks leading up to that moment.The cause of death is reported to be infective exacerbation of chronic obstructive pulmonary disease of five days and end stage chronic obstructive pulmonary disease of more than five years.It was reported the patient's prescription was for 2l/min but in practice it was more like 2.5l/min.The reporter stated that they have records of oxygen saturation readings, hospital and ambulance reports, and other documentation that clearly show the progressive impact this fault had on their father¿s health.Since this device was reported to have been destroyed by the family.No device evaluation will be possible.The second device will be reported on and device evaluation tracked through pr (b)(4) (mfr report number: 2518422-2025-111947).

• 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: 23514271
• Report Number: 2518422-2025-111678
• Device Sequence Number: 9705185
• Product Code: CAW
• UDI-Device Identifier: 00606959001077
• UDI-Public: 00606959001077
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 11/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Death
• Patient Sex: Unknown