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

Model Number	AHX500S11
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Bronchitis (1752); Chronic Obstructive Pulmonary Disease (COPD) (2237); Unspecified Respiratory Problem (4464)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
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 manufacturer received information alleging an issue related to a dreamstation auto cpap device's sound abatement foam.The patient has alleged lung disease, chronic bronchitis, copd.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
H3 other text : device has not been yet returned to the manufacturer.
Additional Manufacturer Narrative
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 manufacturer received information alleging an issue related to a dreamstation auto cpap device's sound abatement foam.The patient has alleged lung disease, chronic bronchitis and copd.The device was returned to the third-party service center for further evaluation.During the evaluation of the device at the third-party service center, the device was visually inspected and found no evidence of foam degradation.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the third-party service center.The third-party service center concludes that they couldn't confirm the customer's allegation and there was no visible foam degradation and unit got scrapped.Box h6: evaluation method code grid evaluation results code conclusion code grid has been 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: 19006277
• Report Number: 2518422-2024-16162
• Device Sequence Number: 18501354
• Product Code: BZD
• UDI-Device Identifier: 00606959022553
• UDI-Public: 00606959022553
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: AHX500S11
• Device Catalogue Number: AHX500S11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2016
• 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: Other
• Patient Sex: Unknown