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	07/28/2025
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information that a patient with a simplygo portable oxygen concentrator device has passed away.The patient¿s wife reported the death and stated that her durable medical equipment (dme) provider had indicated she might receive payment upon returning the device.She was advised that the manufacturer does not offer compensation for returned devices.There was no allegation that the device contributed to the patient's death.No further details were provided.The device has not been returned for investigation.The device has not been returned for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• 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: 22698271
• Report Number: 2518422-2025-108633
• Device Sequence Number: 8869535
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2018
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown