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

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	07/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information related to a simplygo mini oxygen concentrator.The device was returned to a third-party service center.There is no allegation of patient harm, serious injury, or medical intervention.The device was returned to an authorized service center for evaluation.The device was visually inspected.During the evaluation the service center found pca was burned.In addition, sieve canister is clogged, o2 side is defective, air side and inlet filter are contaminated.Lastly all test result passed.

• 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: 19805079
• Report Number: 2518422-2024-46406
• Device Sequence Number: 7496467
• Product Code: CAW
• UDI-Device Identifier: 00606959032439
• UDI-Public: 00606959032439
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2015
• 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