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

Model Number	1020014
Medical Device Problem Codes	No Audible Alarm (1019); Failure to Deliver (2338)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a patient experienced severe shortness of breath while using an everflo device.The patient's spouse called the emt who checked the device.The device had no flow coming from the outlet.The device settings during the event were reported to be 4.5-5l and a green light was showing.There were no audible or visual alarms at the time.The patient is currently hospitalized.The device was evaluated by the service technician.During the evaluation it was found that the nipple on the final bacterial filter (between the flow meter and patient outlet) had snapped in half, thus delivering the oxygen to the inside of the machine and not the patient, however, no alarm conditions occurred.The device has been forwarded to the manufacturer for further investigation.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported the manufacturer received information alleging a patient experienced severe shortness of breath while using an everflo device.The patient's spouse called the emt who checked the device.The device had no flow coming from the outlet.The device settings during the event were reported to be 4.5-5l and a green light was showing.There were no audible or visual alarms at the time.The patient is currently hospitalized.The device was evaluated by the service technician.During the evaluation it was found that the nipple on the final bacterial filter (between the flow meter and patient outlet) had snapped in half, thus delivering the oxygen to the inside of the machine and not the patient, however, no alarm conditions occurred.The device was received by the manufacturer service center for evaluation and the customer's complaint of no flow and no audible or visual alarm was confirmed.During evaluation it was noted that no flow and no audible or visual alarm is due to the micro-disk filter barb being broken off in the tubing indicating embrittlement of the plastic housing of the mico-disk filter.This caused the no flow out of the cannula.Additionally, brown discoloration of the inlet tubing of the compressor indicates tobacco use.The visual and audible alarms performed at start up.The service center was unable to perform testing on the device due to the micro-disk filter barb being broken off in the tubing.The device appears to need preventative maintenance and servicing.Should further investigation provide new information that impacts the outcome of the investigation or the associate medical device reporting, a supplemental report will be submitted accordingly.Based on the information currently provided and available, it was alleged that during clinical and therapeutic use of the everflo quiet 120v op, the patient got progressively short of breath, spouse called the emt, who checked the concentrator and found that there was no flow coming from the outlet of the device despite being set to 5l.Green light was showing and there was no audible or visual alarms at the time, indicating to client that the machine was functioning when it was not.The patient is currently hospitalized.This adverse event has been assessed as a serious injury severity 2.Further review of er 2246289 v06 has linked the alleged malfunction to 13.1.The predicted severity associated with this risk tag is congruent with the allegation of patient harm as severity 2.Pms clinical expert recommends escalation due to 1.1.1.1.1-confirmed cause and/or contribution of the device to a patient¿s death or serious injury.No further escalation is required.

• 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: 24503294
• Report Number: 2518422-2026-007721
• Device Sequence Number: 18670947
• Product Code: CAW
• UDI-Device Identifier: 00606959032620
• UDI-Public: (01)00606959032620
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: 1020014
• Device Catalogue Number: 1020014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female