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

Model Number	1113604
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a work order reporting an issue with a simplygo mini device.During the evaluation process a simplygo mini device was identified with a defective pca in accordance with document (b)(4) appendix a part number: 1124287b431 the device experienced a thermal event resulting in burn marks.There was no report of serious or permanent harm or injury and no medical intervention was required for the patient.The device has not yet been returned to the manufacturer for evaluation if additional information is received a followup report will be filed.
Event or Problem Description
A simplygo mini device was returned to a third-party service center with an initial allegation of won¿t turn on.There was no report of serious or permanent harm or injury, and no medical intervention was required by the patient.During the evaluation of the device at the third-party service center, the device was inspected, and the technician noticed that the pca is burnt.Additionally, this device has been serviced, inspected, tested, and met acceptance criteria in accordance with all the applicable customer requirements.The device will be returned to the manufacturer product investigation laboratory for further investigation.
Additional Manufacturer Narrative
In the previous report, the ¿become aware date¿ and ¿due date¿ were incorrect and have now been corrected.Additionally, the h6 evaluation method code grid was identified as inaccurate and has been properly updated, and the b5 verbiage has been accurately revised in this follow-up report.

• 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: 23591745
• Report Number: 2518422-2025-111918
• Device Sequence Number: 10000505
• Product Code: CAW
• UDI-Device Identifier: 00606959032422
• UDI-Public: (01)00606959032422
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 1113604
• Device Catalogue Number: 1113604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2023
• 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