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

Model Number	GBX500S15
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Death
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The patient has passed away.The device was returned to the manufacturer service center for evaluation.The device was visually inspected by the service technician.Evaluation result stated that the complaint was not confirmed and found no evidence of visible foam degradation.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
Additional Manufacturer Narrative
The manufacturer previously contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The patient has passed away.The device was returned to the manufacturer service center for evaluation.The device was visually inspected by the service technician.Evaluation result stated that the complaint was not confirmed and found no evidence of visible foam degradation.The correct event description should be - the manufacturer received information regarding a dreamstation auto cpap.The patient has passed away.The device was returned to the third-party service center for evaluation.The device was visually inspected by the service technician.Evaluation result stated that the device passed all tests.The complaint was originally reported under the recall, but after further review it was determined this complaint should not have been filed under the recall.Therefore, box d, g and h has been updated or corrected in this report.

• 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: 20195576
• Report Number: 2518422-2024-58054
• Device Sequence Number: 7676454
• 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
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: GBX500S15
• Device Catalogue Number: GBX500S15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 08/11/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1974-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown