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

Model Number	RGBX500S15
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	11/09/2023
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging an issue related to a dreamstation auto cpap device's sound abatement foam.The patient has passed away.The device was returned to the service center for further evaluation.During evaluation of the device at the service center, there was no evidence of foam particles found inside the assembly.The device was scrapped.
Event or Problem Description
The manufacturer received information alleging an issue related to a dreamstation auto cpap device's sound abatement foam.The patient has passed away.The device was returned to the service center for further evaluation.During evaluation of the device at the service center, there was no evidence of foam particles found inside the assembly.The device was scrapped.
Additional Manufacturer Narrative
The manufacturer previously received information alleging an issue related to a dreamstation auto cpap device's sound abatement foam.The patient has passed away.The device was returned to the service center for further evaluation.During evaluation of the device at the service center, there was no evidence of foam particles found inside the assembly.The device was scrapped.The report initially had error box b.In this report it is corrected and 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: 20572769
• Report Number: 2518422-2024-67206
• Device Sequence Number: 20857039
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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?: Yes
• Operator of Device: Other
• Device Model Number: RGBX500S15
• Device Catalogue Number: RGBX500S15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2020
• 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; Other
• Patient Sex: Unknown