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

Model Number	1113602
Medical Device Problem Codes	Corroded (1131); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As per work order:received 4/22: black residue in tubing.Air side-blackend.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.
Additional Manufacturer Narrative
The manufacturer previously reported information in reference to black residue in tubing air side-blackened.The following sections were corrected: complete? the initial complaint should have been filed as a final report.Complete? field has been updated to 'yes' to reflect this.
Additional Manufacturer Narrative
The manufacturer previously reported: as per work order: received 4/22: black residue in tubing air side-blackened.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.Upon review this report was sent in error.The information of black residue is consistent with environmental issues.This is not a reportable event.Cleaning or replacing the tubing and inlet filter is part of routine maintenance.In addition, there is no evidence that the device malfunctioned in a manner that would be likely to cause or contribute to death or serious injury if it were to recur.This complaint is not reportable to any regulatory agencies.

• Brand Name: SIMPLYGO MINI
• 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 ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 22044508
• Report Number: 2518422-2025-105833
• Device Sequence Number: 15673477
• Product Code: CAW
• UDI-Device Identifier: 00606959032408
• UDI-Public: (01)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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 10/28/2025; 04/03/2026
• Date Device Manufactured: 09/18/2019
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown