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

Model Number	1100403
Medical Device Problem Codes	Thermal Decomposition of Device (1071); No Apparent Adverse Event (3189); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This notification was opened for review for information received that the simplygo device was returned to a third-party service center for evaluation with an allegation of low o2.During the evaluation the device was visually inspected and found the following: burnt pca and burn marks were found, leakage in sieves, inlet filter had to be replaced due to preventive maintenance, pca o2 sensor was defective, pressure valves and exhaust valves were old and the tubing kit and muffler were contaminated.The third-party servicer has been instructed to return the device and affected component to the manufacturer for further investigation.
Additional Manufacturer Narrative
The manufacturer previously reported information regarding a simplygo device that was returned to a third-party service center for evaluation with an allegation of low o2.During the evaluation the device was visually inspected and found the following: burnt pca and burn marks were found, leakage in sieves, inlet filter had to be replaced due to preventive maintenance, pca o2 sensor was defective, pressure valves and exhaust valves were old and the tubing kit and muffler were contaminated.The third-party servicer has been instructed to return the device and affected component to the manufacturer for further investigation.Once additional information is received, a follow up report will be filed.

• 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: 23709051
• Report Number: 2518422-2025-112236
• Device Sequence Number: 18821590
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2026

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: 1100403
• Device Catalogue Number: 1100403
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 11/24/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/03/2026; 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2014
• 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