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

Model Number	1113607
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A simply go mini device was returned to a third-party service center in reference to a request for servicing the sieve filter.During the initial evaluation of the device, the third-party service center visually inspected the unit and found the top of the enclosure dented and burned.There was no allegation of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported that a simply go mini device was returned to a third-party service center in reference to a request for servicing the sieve filter.During the initial evaluation of the device, the third-party service center visually inspected the unit and found the top of the enclosure dented and burned.There was no allegation of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.During evaluation and repair of the device, the third-party service center noted that the housing was bent/dented.No report of thermal damage was noted.The front and rear housing was replaced.It was also noted that the sieves are leaking, air side is cracked, o2 side is leaking, and inlet filter has to be replaced due to preventive maintenance.This device was serviced, inspected, and tested.All testing of the device passed.The manufacturer is submitting a final report at this time.

• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 21964476
• Report Number: 2518422-2025-105208
• Device Sequence Number: 7227164
• Product Code: CAW
• UDI-Device Identifier: 00606959033825
• UDI-Public: (01)00606959033825
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 08/18/2025

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: 1113607
• Device Catalogue Number: 1113607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2017
• 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