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

Model Number	1113604
Medical Device Problem Codes	Circuit Failure (1089); Display or Visual Feedback Problem (1184); Gas Output Problem (1266); Temperature Problem (3022); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The device was returned to the third-party service center.During the evaluation of the device at the third-party service center, the device was visually inspected and found main pca is burnt.Additionally, sieves are clogged, display is damage and non-operational, air side and o2 side are leaking, inlet filters need to be changed due to preventive maintenance.The customer complaint was reproduced.The customer complaint was reproduced.There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The device has not yet been returned to the manufacturer for evaluation.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously received information alleging an issue with the screen related to the device simplygo mini electric ventilator.The device was returned to the third-party service center.During the evaluation of the device at the third-party service center, the device was visually inspected and found main pca is burnt.Additionally, sieves are clogged, display is damage and non-operational, air side and o2 side are leaking, inlet filters need to be changed due to preventive maintenance.The customer complaint was reproduced.There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The device has not yet been returned to the manufacturer for evaluation.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Previously mentioned event description was incorrect.The correct/updated event description should be- the manufacturer received information alleging an issue with the screen related to the device simplygo mini electric ventilator.There was no report of patient harm or injury.The device was returned to the third-party service center for further evaluation.During the evaluation of the device at the third-party service center, the device was visually inspected and found thermal event as the main pca is burnt.There was no evidence of foam degradation found during evaluation.Additionally, sieves are clogged, display is damage and non-operational, air side and o2 side are leaking, inlet filters need to be changed due to preventive maintenance.Compressor inlet filter, sieves, pca, front cover, o2 side, air side were replaced.The customer complaint was reproduced.In this report, box h, b has been updated or corrected.

• Brand Name: SIMPLYGO MINI
• Common Device Name: PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 21201022
• Report Number: 2518422-2025-006053
• Device Sequence Number: 15339644
• Product Code: CAW
• UDI-Device Identifier: 00606959032422
• UDI-Public: (01)00606959032422
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2016
• 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