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

Model Number	1113602
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a work order invoice for a simlygo mini oxygen concentrator due to the sieve was found saturated, , the power connector was cracked, the filter was dirty, and the shipping carton sg mini was missing.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.

• Brand Name: SIMPLYGO MINI
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• 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: 21268046
• Report Number: 2518422-2025-009488
• Device Sequence Number: 8496045
• Product Code: CAW
• UDI-Device Identifier: 00606959032408
• UDI-Public: (01)00606959032408
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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: 1113602
• Device Catalogue Number: 1113602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown