MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	GBX500S15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a patient with a rental-dreamstation auto cpap passed away.There was no allegation that the device contributed to the death.Additional information has been requested regarding the details of the reported death.The manufacturer's investigation is ongoing.A follow up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Previously reported as, "the manufacturer received information alleging a patient with a rental-dreamstation auto cpap passed away.There was no allegation that the device contributed to the death.Additional information has been requested regarding the details of the reported death.The manufacturer's investigation is ongoing.A follow up report will be submitted when the manufacturer's investigation is complete".In this report, in this report, box b: adverse event or product problem (describe event or problem) as the manufacturer received information alleging a patient with a rental-dreamstation auto cpap passed away.There was no allegation that the device contributed to the death.The device was returned to third party service center and evaluated.Evaluation result stated that no foam particles were observed.The manufacturer is submitting a final report at this time.If any additional information becomes available to the manufacturer at a later date, an addendum to this final report will be filed, box d: suspect medical device (operator of device), box g: all manufacturers (report source), box h: device manufacturers (evaluation method code grid, evaluation results code grid, conclusion code grid) have been corrected/updated.

• Brand Name: DREAMSTATION AUTO CPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 19993278
• Report Number: 2518422-2024-51659
• Device Sequence Number: 7076017
• Product Code: BZD
• UDI-Device Identifier: 00606959042285
• UDI-Public: (01)00606959042285
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: Other
• Device Model Number: GBX500S15
• Device Catalogue Number: GBX500S15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2022
• 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