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

Model Number	1133942
Medical Device Problem Codes	Gas/Air Leak (2946); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information regarding a simplygo mini.The device was returned to the manufacturer's service center.During the device investigation, a sieve alarm displayed a message stating, "sieve canister needs checked".The canister assembly was replaced.The silicone tube was found to have been worn away by contacting the rear case.The silicone tube was replaced.During further investigation of the device, a leak was found within the device.The sieve o2 side assembly was replaced as a result.During operation of the device, a noise was detected.The airside manifold was replaced as a result.Damage to the appearance of the ac power adapter was observed.The ac power adapter was subsequently replaced.No thermal damage nor any exposed wires were present.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.

• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18341290
• Report Number: 2518422-2023-35936
• Device Sequence Number: 8489448
• Product Code: CAW
• UDI-Device Identifier: 00606959047433
• UDI-Public: 00606959047433
• 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,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: 1133942
• Device Catalogue Number: 1133942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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