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

Model Number	1113605
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to simplygo mini device.There was an initial allegation of smoke coming out from the device.Additionally, battery power being low and very loud noise knocking at level 5.There was no report of patient harm or injury.There was no report of medical intervention.The device has not yet been returned to the manufacturer for evaluation.Should any additional information be received, a follow-up report will be filed.
Additional Manufacturer Narrative
The manufacturer was contacted in reference to simplygo mini device.There was an initial allegation of smoke coming out from the device.Additionally, battery power being low and very loud noise knocking at level 5.There was no report of patient harm or injury.There was no report of medical intervention.A simplygo mini device was returned to a third-party service center for evaluation.During the evaluation of the device at the third-party service center, the device was visually inspected.The service technician found that compressor was loud, sieve was clogged, battery had over 450 cycles and must be replaced, air side leak, o2 side screw thread was damaged.In addition, device had no signs of burns or smoke and was updated to latest version.Additionally, the device was scrapped.Box h has been updated.

• 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: 23843658
• Report Number: 2518422-2025-112865
• Device Sequence Number: 18631546
• Product Code: CAW
• UDI-Device Identifier: 00606959032439
• UDI-Public: (01)00606959032439
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 1113605
• Device Catalogue Number: 1113605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2020
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown