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

Model Number	1069058
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation of simplygo stating that the device has a clogged siev, compressor does not work in normal parameters.Pca is defective and has burnt components.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Correction to device problem code and evaluation results code.
Additional Manufacturer Narrative
The manufacturer previously became aware of an allegation of simplygo device.The device was returned to the service center for evaluation.The device had a clogged sieve; compressor did not work in normal parameters.Pca was defective and had burnt components.Tubing kit needed to be replaced, check valve cover kit was broken.The sieve canister was depleted.Inlet filter was replaced due to preventive maintenance.Faulty component was returned to philips investigation lab for further investigation.The device was repaired and passed the overall test which included decontamination, evaluation, repair, functional test, quality inspection and packaging.Additionally, pca (only) forwarded to manufacturer's product investigation laboratory after 3rd party servicing discovered vented pca components.The thermal event was confirmed.Pca compressor driver fets vented and have been overstressed beyond design.Compressor driver fet¿s shorted/open and no longer functional.Indicative of overstressed compressor pressures from system sieve compaction (high pressure condition).In this report, box d, h has been updated/ corrected.

• Brand Name: SIMPLYGO
• 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: 19978598
• Report Number: 2518422-2024-51307
• Device Sequence Number: 8141404
• Product Code: CAW
• UDI-Device Identifier: 00606959020801
• UDI-Public: (01)00606959020801
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2025

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: Other
• Device Model Number: 1069058
• Device Catalogue Number: 1069058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: Not provided; 05/30/2025
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 11/05/2024; 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• 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