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

Model Number	1069058
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A simplygo device was returned to a third-party service center with an initial allegation of the device showing a power issue.There was no report of serious or permanent harm or injury.There was no report of medical intervention.During the evaluation of the device at the third-party service center, the debug technician noticed that the pca is burnt and the rp-simly go pca needs to be changed.Additionally, the device was returned to the pil for further investigation.
Additional Manufacturer Narrative
This report is being sent to correct our previous submission.Report information, complete? updated to no.

• 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 ; 7247330200
• MDR Report Key: 24465050
• Report Number: 2518422-2026-006892
• Device Sequence Number: 9581107
• Product Code: CAW
• UDI-Device Identifier: 00606959020801
• UDI-Public: (01)00606959020801
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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
• Device Model Number: 1069058
• Device Catalogue Number: 1069058
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2020
• 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