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

Model Number	1020007
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging that during routine maintenance performed by the customer on an everflo device, it was discovered that an equipment's flow meter indicated a correct flow rate (5 l/min), but no actual flow was reaching the patient outlet.The equipment did not trigger an alarm.Further investigation by the customer revealed that the internal patient filter had split, causing a flow leak inside the device.The defective filter lacked a lot or batch number, as it had been replaced during earlier service.Upon checking storage, it was found that there were other filters found to be defective or partially coming apart.This poses a risk because patients may unknowingly receive inadequate flow.The issue may have persisted for a long time, as the affected filter had been in use for 1.5 years.No patient harm or injury was reported as the device was not in patient use at the time.Despite three good faith-effort attempts on 10/14/2025, 01/22/2026, and 02/18/2026 to (b)(6), the device has not yet been returned to the manufacturer for evaluation.At this time, no further investigation can be completed.If any additional information is received at a later date, a supplemental report will be filed.

• Brand Name: EVERFLO INTL OPI
• 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: 24620735
• Report Number: 2518422-2026-009671
• Device Sequence Number: 18698185
• Product Code: CAW
• UDI-Device Identifier: 00606959032569
• UDI-Public: (01)00606959032569
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1020007
• Device Catalogue Number: 1020007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2016
• 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
• Patient Sex: Unknown