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

Model Number	1069058
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The device was sent to a third-party service center for investigation.During evaluation, the third-party service center found burned pca (could not read hours), sieves are clogged, inlet filter will be replaced due to preventative maintenance.Due to the alleged malfunction, the device will be forwarded to the manufacturer¿s product investigation lab (pil) for additional testing and investigation.A final report will be sent once the investigation is concluded.
Additional Manufacturer Narrative
The manufacturer previously reported information that a simplygo device was sent to a third-party service center for investigation.During evaluation, the third-party service center found burned pca (could not read hours), sieves are clogged, inlet filter will be replaced due to preventative maintenance.Due to the alleged malfunction, the device will be forwarded to the manufacturer¿s product investigation lab (pil) for additional testing and investigation.The device has not been evaluated by the manufacturer¿s product investigation lab (pil) for additional testing and investigation at this time.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: SIMPLYGO
• 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: 23657895
• Report Number: 2518422-2025-112121
• Device Sequence Number: 4825199
• Product Code: CAW
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/23/2026

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: 1069058
• Device Catalogue Number: 1069058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 11/23/2025; 07/21/2026; 09/23/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 05/04/2026; 07/21/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2021
• 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
• Patient Sex: Unknown