MAUDE Adverse Event Report: Respironics, Inc. EverFlo; Generator, Oxygen, Portable

Model Number	1020007
Medical Device Problem Codes	Defective Alarm (1014); Failure to Deliver (2338)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging that a patient using an everflo oxygen concentrator experienced insufficient oxygen delivery during clinical and therapeutic use.The patient's daughter reported that the patient's peripheral oxygen saturation (spo2) decreased to 70% for an unspecified period of time, with no device alarm sounding during the alleged event.The patient's condition reportedly deteriorated, resulting in ems transport to a hospital and subsequent admission.The device underwent an initial inspection by a technical service team, including testing of the pressure delivery system and alarm conditions related to flow and fio2.The device passed the preliminary testing, and the alarms functioned as intended during simulated low-flow and decreased fio2 conditions.It was noted that the device had been in use for approximately 5,100 hours over the past 7 months (equivalent to 24 hours per day) and had accumulated a corresponding amount of dust.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• 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 ; +1(724)733-0200
• MDR Report Key: 50309251
• Report Number: 2518422-2026-043439
• Device Sequence Number: 10135540
• Product Code: CAW
• UDI-Device Identifier: 00606959032569
• UDI-Public: (01)00606959032569
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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: Other
• Device Model Number: 1020007
• Device Catalogue Number: 1020007
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2023
• 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: Hospitalization; Life Threatening
• Patient Sex: Unknown