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

Model Number	1069058
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a simplygo device involving fire.There was no initial report of patient harm or injury.There was no report of medical intervention.Additional information received from a gfe attempt via email states, "the patient had used the portable oxygen concentrator during a 3-hour consultation on (b)(6) 2024.Upon returning home, they plugged in the device to charge.About an hour later, the equipment caught fire.The patient was using the poc plugged into the power outlet when the incident occurred.After vitalaire's visit to the patient, it was clarified that the fire was limited to the consumables (extension/cannula), not the concentrator itself.The possible primary cause was identified as the patient smoking while using the poc." damage reported was described as occurring only in the consumables (extension/cannula).Specifically, there was one end of the extension or cannula that was burned and melted.The device itself was not damaged.The device has not yet been returned to the manufacturer for evaluation; however, has been sent to the manufacturer for analysis.If any additional information is received, a follow-up report will be filled.
Additional Manufacturer Narrative
The manufacturer previously reported information alleging an issue related to a simplygo device involving fire.There was no initial report of patient harm or injury.There was no report of medical intervention.Additional information received from a gfe attempt via email states, "the patient had used the portable oxygen concentrator during a 3-hour consultation on (b)(6), 2024.Upon returning home, they plugged in the device to charge.About an hour later, the equipment caught fire.The patient was using the poc plugged into the power outlet when the incident occurred.After vitalaire's visit to the patient, it was clarified that the fire was limited to the consumables (extension/cannula), not the concentrator itself.The possible primary cause was identified as the patient smoking while using the poc." damage reported was described as occurring only in the consumables (extension/cannula).Specifically, there was one end of the extension or cannula that was burned and melted.The device itself was not damaged.The device was returned to the manufacturer third-party service center.During the evaluation of the device, the third-party service center visually inspected the device it was overserved that the sieves are clogged, check valve cover is cracked, muffler and tubing kit are aged, spine screw holes are cracked, inlet filter has to be replaced due to preventive maintenance and battery is defective, won't charge properly.The device was returned unrepaired as requested by the customer.At this time, no further investigation can be performed.If any 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 ; 7247330200
• MDR Report Key: 23559860
• Report Number: 2518422-2025-111837
• Device Sequence Number: 21247704
• Product Code: CAW
• UDI-Device Identifier: 00606959020801
• UDI-Public: (01)00606959020801
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,Followup
• Report Date (Section B): 02/03/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2015
• 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