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

Model Number	BRX500S18
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused respiratory diseases.The patient did report to receive medical intervention and was hospitalized in the intensive care unit and had several medical tests.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer received information alleging a cpap device's sound abatement foam became degraded and the patient developed respiratory diseases.The patient did report to receive medical intervention in the form of hospitalization in the intensive care unit and was sent for medical tests.The device was returned to the manufacturer for investigation.Upon receipt, the device was found to have recorded 4190.4 blower hours and 4153.3 therapy hours.During the evaluation of the device at the service center the device log files were successfully downloaded and reviewed in full.No actionable errors were identified in the log files.In addition, there was no evidence of foam degradation.The customer complaint was not confirmed.The device was scrapped.The manufacturer has updated h6 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7243512041
• MDR Report Key: 14456830
• Report Number: 2518422-2022-22968
• Device Sequence Number: 17318342
• Product Code: BZD
• UDI-Device Identifier: 00606959041134
• UDI-Public: 00606959041134
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BRX500S18
• Device Catalogue Number: BRX500S18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2018
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Unknown