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

Model Number	1069058
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to the device simplygo.The device was returned to the manufacturer authorized service center and evaluation result found burnt pca.Pca, inlet filter sieve, compressor was replaced although there was no reported patient death or serious injury, this complaint is reportable because the reported issue/event could potentially cause or contribute to a death or serious injury if the malfunction were to recur.

• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 21730358
• Report Number: 2518422-2025-103487
• Device Sequence Number: 4222833
• Product Code: CAW
• UDI-Device Identifier: 00606959020801
• UDI-Public: (01)00606959020801
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: 1069058
• Device Catalogue Number: 1069058
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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