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

Model Number	R1133943
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging patient was in hospital due to his spo2 temporarily dropped to 77% but after switching to oxygen inhalation, it recovered to around 95%.The report said that the device alarmed change to another source of oxygen thus leading to the patient being placed on o2 and recovering from symptoms.Therefore, the device worked as intended by letting the patient know oxygen was low and a different source was needed.There was report of serious or permanent harm or injury.Device was evaluated, during the evaluation of the device was visually inspected, and the sieve canister was also replaced as maintenance in accordance with the repair.Since noise was confirmed by an operation check, the air side manifold was replaced.Confirmed by an operational check that the alarm sound and the operation sound were small.Therefore, the alarm/tilt sensor was replaced.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
Evaluation method code grid, evaluation results code grid and conclusion code grid have been corrected/updated in this follow-up report.

• Brand Name: SIMPLYGO MINI
• Common Device Name: PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 20793201
• Report Number: 2518422-2024-071975
• Device Sequence Number: 12470658
• 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
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: R1133943
• Device Catalogue Number: R1133943
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male