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

Model Number	DSX500H11W
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	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of a rep dreamstation auto cpap, dom - recrt device alleging visualization of particles.There is no allegation of serious or permanent harm or injury.There was no report of medical intervention.No additional information can be requested at this time.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 became aware of a rep dream station auto cpap, dom - recrt device alleging visualization of particles.There is no allegation of serious or permanent harm or injury.There was no report of medical intervention.No additional information can be requested at this time.The device was returned to the third-party service center for further evaluation.During the evaluation of the device at the third-party service centre, the device was visually inspected and found no evidence of foam degradation.During the evaluation, secondary findings was observed.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the third-party service centre.There was no error code found.The third-party service center concludes that they couldn't confirm the customer's allegation and there were no visible foam degradation and unit got corrected.Evaluation method code, evaluation results code and conclusion code grid has been updated.
Additional Manufacturer Narrative
Correction to the previously reported information: 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.This report was related to a dreamstation auto cpap.The manufacturer received information from the patient alleging visualization of particles.Medical intervention was not specified.The device was returned to the third party service center for evaluation.During the evaluation of the device at the third-party service center, the device was visually inspected and visible foam particles were not observed.Additionally, the patient¿s complaint was not confirmed, and the device was corrected.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.The device information has been corrected in this report.This product is listed under the scope of recall.In this report, box d, h has been updated/corrected.

• 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 ; 7247330200
• MDR Report Key: 21462634
• Report Number: 2518422-2025-022345
• Device Sequence Number: 12926355
• Product Code: BZD
• UDI-Device Identifier: 00606959034112
• UDI-Public: (01)00606959034112
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 01/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DSX500H11W
• Device Catalogue Number: DSX500H11W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 12/27/2022; 01/29/2026
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 11/10/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2018
• 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
• 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
• Patient Sex: Unknown