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

Model Number	1068987
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2024
Type of Reportable Event	Death
Event or Problem Description
The manufacturer was contacted in reference to a customer requesting information on returning a simply go device due to a patient passing.There is no allegation of device malfunction.There is no allegation that the device contributed to the patient death.No other information is available at this time.This report is being submitted for an allegation of a patient death only due to insufficient information related to the device.The device has not been returned to the manufacturer for investigation.The manufacturer investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported in reference to a customer requesting information on returning a simply go device due to a patient passing.There is no allegation of device malfunction.There is no allegation that the device contributed to the patient death.No other information is available at this time.This report is being submitted for an allegation of a patient death only due to insufficient information related to the device.The device was returned to a third-party service center.During the evaluation of the device, the service technician noted that the pca does not detect o2% level.The pca was replaced and all functional and quality checks passed.The device was scrapped by the service center after the evaluation was completed at the customer¿s request.

• 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: 20563622
• Report Number: 2518422-2024-102889
• Device Sequence Number: 7532089
• Product Code: CAW
• UDI-Device Identifier: 00606959005723
• UDI-Public: (01)00606959005723
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 08/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown