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

Model Number	1113601
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to a simplygo portable oxygen concentrator device.The patient alleges for credit request.No information was reported regarding the observation of any flames or evidence of melting, warping, or any voids in the device enclosure.There was also no report of any property damage.During evaluation of the device, the secondary finding is observed that corrosion on main pca, and pca need to replace, and unit is scrapped.

• Brand Name: SIMPLYGO MINI
• Common Device Name: PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 22852223
• Report Number: 2518422-2025-048950
• Device Sequence Number: 18248119
• Product Code: CAW
• UDI-Device Identifier: 00606959032392
• UDI-Public: (01)00606959032392
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/20/2025

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: 1113601
• Device Catalogue Number: 1113601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2022
• 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