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

Model Number	1133943
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to a simplygo mini device.There was an allegation of charging connector had deteriorated, and the cable had broken near the connection point.The cable was replaced with a new one.When it was connected to an outlet in the office as a test, a sparking sound was observed.There was no report of patient harm or injury.There was no report of medical intervention.The device has not yet been returned to the manufacturer for evaluation.The manufacturer investigation is ongoing.A follow report will be submitted when manufacturer investigation is complete.

• Brand Name: SIMPLYGO MINI
• Common Device Name: PORTABLE OXYGEN CONCENTRATOR
• 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: 24653949
• Report Number: 2518422-2026-009851
• Device Sequence Number: 6088115
• Product Code: CAW
• UDI-Device Identifier: 00606959047440
• UDI-Public: (01)00606959047440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 1133943
• Device Catalogue Number: 1133943
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/24/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2020
• 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