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

Model Number	1020007
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.
Event or Problem Description
This notification was opened for review for information received that a customer using an everflo device stating, "the concentrator caused a short circuit." there is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not yet been returned for evaluation.Should any additional information be received, a follow-up report will be filed.
Additional Manufacturer Narrative
This notification was opened for review for information received that a customer using an everflo device stating, "the concentrator caused a short circuit." there is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.During the evaluation of the device, the sieves were clogged and the inlet filter needs to be replaced for preventive maintenance.The service technician confirmed that a thermal event did not occur.The device has been serviced, inspected, tested, and returned to client.This event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury and/or reportable product malfunction.

• 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: 24877533
• Report Number: 2518422-2026-010875
• Device Sequence Number: 10029370
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown