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

Model Number	1098834
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information from a third-party service center work order for a simplygo device, which alleged melted filter.Additionally, the pca was also found to be damaged, sieve canister was faulty, and the compressor was making an abnormal noise.The device has not yet been returned to the manufacturer for evaluation.Should any additional information be received, a follow-up report will be filed.
Additional Manufacturer Narrative
This final report is being submitted to correct the b5 statement and update related fields.The simplygo device was sent to a third-party service center for evaluation.The work order indicated that the device had a melted filter.Additionally, the pca was also found to be damaged, the sieve canister was faulty, and the compressor was making an abnormal noise.The device was not reported to be in clinical use at the time of the incident.There was no death, serious harm or injury, and no medical intervention was reported.
Event or Problem Description
The simplygo device was sent to a third-party service center for evaluation.The work order indicated that the device had a melted filter.Additionally, the pca was also found to be damaged, the sieve canister was faulty, and the compressor was making an abnormal noise.The device was not reported to be in clinical use at the time of the incident.There was no death, serious harm or injury, and no medical intervention was reported.

• 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: 23425802
• Report Number: 2518422-2025-111355
• Device Sequence Number: 8253191
• Product Code: CAW
• UDI-Device Identifier: 00606959028838
• UDI-Public: (01)00606959028838
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 11/17/2025

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: 1098834
• Device Catalogue Number: 1098834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• 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