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

Model Number	1098834
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a simplygo device's thermal event.The manufacturer received information alleging that the device has ¿melted filter¿.Additionally, the complaint was confirmed for alarming, no power, found sieve canister failure and damaged main pca.There was no serious patient harm or injury.The patient required no medical intervention.At this time, no medical intervention has been reported, and no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
The report was earlier sent as initial but it is updated/corrected in this report.B5 verbiage: the simplygo device was returned to a third-party service center, the device was visually inspected and found device has ¿melted filter¿.Additionally, the complaint was confirmed for alarming, no power, found sieve canister failure and damaged main pca.At this time, no medical intervention has been reported, and 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: PORTABLE OXYGEN CONCENTRATOR
• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 22118302
• Report Number: 2518422-2025-106228
• Device Sequence Number: 6950687
• Product Code: CAW
• UDI-Device Identifier: 00606959028838
• UDI-Public: (01)00606959028838
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: Lay User/Patient
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2022
• 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