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

Model Number	IT1113605
Medical Device Problem Codes	Contamination (1120); Gas Output Problem (1266); Overheating of Device (1437); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A simplygo mini device was returned to a third-party service center for service.There was no report of patient harm or injury.There was no report of medical intervention.During the device evaluation, the third-party service center visually inspected the device and found the unit noisy, low o2, irregular graph compressor contaminated and overheating, sieves recipes clogged, o2 side, airside defective.The device has been serviced, inspected, tested, and met all acceptance criteria.All test results have passed.
Additional Manufacturer Narrative
H3 other text : the device was evaluated by a third-party service center.

• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18554772
• Report Number: 2518422-2024-03785
• Device Sequence Number: 15378478
• Product Code: CAW
• UDI-Device Identifier: 00606959048843
• UDI-Public: 00606959048843
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: IT
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: Other
• Device Model Number: IT1113605
• Device Catalogue Number: IT1113605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2018
• 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