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

Model Number	1113605
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A simply go mini device was returned to a third-party service center for service.During the initial evaluation of the device, the third-party service center visually inspected the unit and found the pca had thermal damage.The device was not in patient use.There was no allegation of patient harm or injury.The unit is being shipped to the manufacturer for further investigation.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 for service.During the initial evaluation of the device, the third-party service center visually inspected the unit and found the pca had thermal damage.The device was not in patient use.There was no allegation of patient harm or injury.The unit is being shipped to the manufacturer for further investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.The device and a repair kit were returned to the philips product investigation lab (pil) for further evaluation.A thorough investigation was conducted on the bench at the product investigation laboratory (pil).It was found that the device returned from the third-party service center performed as intended, providing oxygen therapy as designed.Additionally, it is notable that the pca logs did not provide any evidence of setup or use.The repair kit was ordered for the purpose of servicing or repairing a unit.However, the materials were rejected during incoming inspection and, therefore, never placed into use or service.Consequently, there is no associated risk to patients.The visual inspection yielded no remarkable findings.The materials were placed into a known, good, operational unit, and they functioned as designed without any issues.Pca logs confirmed an issue that occurred during the fasc servicing setup.The materials were returned to the manufacturer with an allegation of fault/failure.Upon investigation, they were found to function properly, with no operational issues detected.As the materials were never placed into use or service, there is no associated risk.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: 22041086
• Report Number: 2518422-2025-105810
• Device Sequence Number: 18407317
• Product Code: CAW
• UDI-Device Identifier: 00606959032439
• UDI-Public: (01)00606959032439
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 07/20/2025

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: 1113605
• Device Catalogue Number: 1113605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/17/2025
• Supplement Report FDA Received Date: 07/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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