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

Model Number	1068987
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information regarding a simplygo device.The reporter alleges the patient passed away while awaiting the return of the simplygo unit.The unit was sent for servicing at a third party service center since june 2022.The patient was using a back up unit (device brand/type not provided) at the time of passing.The family of the patient did not state the device was the cause of the patient expiring.The cause of the patient's death was not provided by the reporter.The device was sent for service due to the sieve bed "went bad".The relative of the patient brought the device to the pharmacy for repair/replacement in (b)(6) 2022.The device was not picked up for servicing from the pharmacy until (b)(6) 2023 although the device was in possession of the pharmacy since october 2022.The patient passed in (b)(6) 2023 (exact date not provided).The relative of the patient thinks the patient passed away because the patient did not have the simplygo device.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
H3 other text : device not returned to the manufacturer.
Additional Manufacturer Narrative
The device was evaluated by the manufacturer's product investigation laboratory (pil) and unable to confirm the allegation of patient death.After running for over an hour it was noted the o2 output was low due to a lack of preventative maintenance.Unit may need servicing/preventative maintenance/upgrades; recommend unit forwarded to service.In this report, box d, g, 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: 18682770
• Report Number: 2518422-2024-06756
• Device Sequence Number: 6195198
• Product Code: CAW
• UDI-Device Identifier: 00606959005723
• UDI-Public: 00606959005723
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1068987
• Device Catalogue Number: 1068987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 02/11/2024
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2021
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown