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

Model Number	1133943
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A simply go mini device was returned to a service center for evaluation.During the evaluation of the device at the service center, the service technician did not confirm the reported problem.However, the service technician found problem where it could not operate on battery power alone.Upon internal inspection, thermal damage was found on component c128 on the main pca.The main pca and esd shield were replaced.No abnormalities were found with the included dc power adapter.The log confirmed a history of alarms indicating a check of the sieve canister, so it was replaced.As part of the repair, the compressor inlet filter was replaced.During inspection, an internal leak was confirmed, so the sieve o2 side assembly was replaced.During the operation check, abnormal noise was detected, so the air side manifold was replaced.Each part was inspected and cleaned, comprehensive inspection and adjustment were performed, and a running test confirmed normal operation.
Event or Problem Description
The manufacturer was contacted in reference to a simply go mini device with an allegation using a car cigarette lighter socket, smoke came out of the socket (on the car side) machine.The device turns off but the standby symbol remains displayed.The patient pulled it out of the socket, so nothing happened.At the site, the cable and equipment of the sega socket were not turned off.Since the condition was poor, they decided to replace it.There was no report of patient harm or injury.There was no report of medical intervention.The device has not yet been returned for evaluation.If the device is returned and evaluated, a follow-up report will be submitted with the evaluation results.

• Brand Name: SIMPLYGO MINI
• 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: 24321516
• Report Number: 2518422-2026-004686
• Device Sequence Number: 13180304
• Product Code: CAW
• UDI-Device Identifier: 00606959047440
• UDI-Public: (01)00606959047440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 1133943
• Device Catalogue Number: 1133943
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2023
• 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