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

Model Number	1068987
Medical Device Problem Codes	Overheating of Device (1437); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging burning smell.The unit was swapped for another device and confirmed that the customer also detected a burning odor and tagged as "out of service" and placed on workbench.Customer attempted to power on the device using the ac adapter but the unit did not respond but noticed the green light on the adapter was flashing rather than remaining solid.Customer stated they tried to power the unit using a fully changed butter but failed to turn on.Contacted the repair center regarding their issues and suggested a possible thermal event and a faulty pc board.There was no patient harm or injury reported with this notification.During the evaluation of the device at the manufacturer product investigation laboratory (pil) for evaluation, pil able to confirm the customer allegation of burning smell due to thermal damage on the pca.The unit arrived at pil without battery and power supply.During the internal inspection it was showed a black residue on the back enclosure (indicative of a thermal event on the pca).Thermal damage on the pca (q2 and q6), sieve cans are the original cans from when the unit was manufacturer.A dust-like contamination in the rear enclosure.Dust-like contamination in front enclosure.In conclusion, the unit had thermal damage to the pca on the compressor motor driving circuit (q2 and q6) which was caused by high pressure from compacted/bridged sieve material.The thermal damage was isolated to the pca substrate.There was no evidence of thermal creep to anywhere else in the unit.

• 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: 24806900
• Report Number: 2518422-2026-010521
• Device Sequence Number: 21499545
• Product Code: CAW
• UDI-Device Identifier: 00606959005723
• UDI-Public: (01)00606959005723
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Other,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: Other
• Device Model Number: 1068987
• Device Catalogue Number: 1068987
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2022
• 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