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

Model Number	1113601
Medical Device Problem Codes	Backflow (1064); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a simplygo mini portable oxygen concentrator was overheating and caused damage to the pc board.There was no report of smoke, flames, or exposed ac wires.There was no report of serious patient harm or injury.There was no report of medical intervention.The device was returned to the manufacturer for evaluation, but the investigation is not yet complete.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 received information alleging a simplygo mini portable oxygen concentrator was overheating and caused damage to the pc board.There was no report of smoke, flames, or exposed ac wires.There was no report of serious patient harm or injury.There was no report of medical intervention.The device was returned to the product investigation lab to further investigate the allegation/fault of ¿"damaged pc board and overheating." although the allegation of "overheating," cannot be reproduced, "damaged pc," is confirmed.However, any perceived failure mode of a thermal event is isolated to several components venting (as designed).No actual evidence of thermal creep exists.Also, no voids in the enclosure can be found.Unit fails to power on/post due to damage caused from liquid ingress and significant corrosion throughout the entire unit.The unit arrived at the product investigation lab without any accessories (external battery pack/psu.) the ui panel was not connected to the unit.Glitter like material was present on the ui panel adhesive.There was black discoloration on the enclosure.A dirt-like material was present on the enclosure.A dirt-like material was throughout the inside of the unit.There was brown discoloration on the compressor outlet tube and oxygen sensor tube.Corrosion and verdigris are present on the ui panel and battery board pca which suggests liquid ingress.The ui panel pca serial number label is discolored, and the adhesive is delaminating which also suggests liquid ingress.Multiple components on the main pca are affected by the liquid ingress.There were no voids observed in the plastic enclosure (no void was mentioned in the complaint).A brown liquid sticky-like substance is noted on q19.Testing was unable to be performed due to the condition of the unit.Unit pca damaged beyond repair (for the purposes of powering up/post testing.) a fault/failure mode (liquid ingress/shorting;) was confirmed; however, unable to confirm a thermal event occurred.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.The manufacturer has updated section h coding in this 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: 20358578
• Report Number: 2518422-2024-101450
• Device Sequence Number: 8127209
• Product Code: CAW
• UDI-Device Identifier: 00606959032392
• UDI-Public: (01)00606959032392
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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: 1113601
• Device Catalogue Number: 1113601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown