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

Model Number	1068987
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2026
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a patient with a simplygo device has passed away.The reported event makes no allegation of any specific device malfunction, use error, failure, labeling, or other deficiency that is relevant to the harms reported; therefore, based on information available at this time, the device did not cause or contribute to a serious injury or death.Additional information has been requested regarding the details of the reported death.
Additional Manufacturer Narrative
This notification was re-evaluated following receipt and review of all available information related to the reported patient death.At the time of initial reporting, the event was conservatively submitted due to the limited information available.However, subsequent review confirms that there is no allegation or evidence suggesting that the device malfunctioned, failed, or otherwise contributed to the reported outcome.Therefore, this case has been reassessed and determined to be non-reportable.The event will continue to be documented and trended per internal quality system requirements.
Additional Manufacturer Narrative
This notification was re-evaluated following receipt and review of all available information related to the reported patient death.At the time of initial reporting, the event was conservatively submitted due to the limited information available.However, subsequent review confirms that there is no allegation or evidence suggesting that the device malfunctioned, failed, or otherwise contributed to the reported outcome.Therefore, this case has been reassessed and determined to be non-reportable.The event will continue to be documented and trended per internal quality system requirements.In the previous report box h was incorrect/wrong.In this report box h has been updated/corrected.
Additional Manufacturer Narrative
In the previous report the section problem code grid in box h was incorrect/ wrong.In this report the section problem code grid in box h was updated/ corrected.This notification was re-evaluated following receipt and review of all available information related to the reported patient death.At the time of initial reporting, the event was conservatively submitted due to the limited information available.However, subsequent review confirms that there is no allegation or evidence suggesting that the device malfunctioned, failed, or otherwise contributed to the reported outcome.Therefore, this case has been reassessed and determined to be non-reportable.The event will continue to be documented and trended per internal quality system requirements.In the previous report box h was incorrect/ wrong.In this report box h has been updated/ corrected.

• Brand Name: SIMPLYGO
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 24737257
• Report Number: 2518422-2026-010184
• Device Sequence Number: 9269557
• Product Code: CAW
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/02/2026

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 05/07/2026; 06/17/2026; 07/02/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/08/2026; 06/17/2026; 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2012
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown