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

Model Number	1113602
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A device was returned to a third party service center for routine maintenance.During the routine maintenance device malfunction were repaired.The maintenance report indicated black residue in tubing, blackened air side.There is no allegation of harm or serious injury.Medical intervention was not reported.
Additional Manufacturer Narrative
The manufacturer was previously received information regarding a simplygo mini device, returned to a third party service center for routine maintenance.During the routine maintenance device malfunction were repaired.The maintenance report indicated black residue in tubing, blackened air side.There is no allegation of harm or serious injury.Medical intervention was not reported.This notification was reviewed for pca-technical fault, comp.-black residue in tubing, sieves-compacted, air side-black end, o2 side-cracked, replaced faulty parts.The allegation has been reviewed by a service center and determined that the allegation of pca-technical fault, comp.-black residue in tubing, sieves-compacted, air side-black end, o2 side-cracked, replaced faulty parts does not qualify as a serious injury.Analysis of past events has not indicated an adverse event has occurred due to the reported allegation.Review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.This event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury and/or reportable product malfunction.

• Brand Name: SIMPLYGO MINI
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19488779
• Report Number: 2518422-2024-34924
• Device Sequence Number: 8500279
• Product Code: CAW
• UDI-Device Identifier: 00606959032408
• UDI-Public: 00606959032408
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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: 1113602
• Device Catalogue Number: 1113602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2021
• 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