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

Model Number	DSX500H11
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A dreamstation auto cpap was returned to a third-party service center.There was no initial alleged complaint found.During the evaluation conducted at the third-party service center, the device was visually inspected, and evidence of foam particles was identified.Additionally, the service technician found dust contamination and the device was scrapped by the service center after the evaluation was completed.This event is reportable under fda 21 cfr part 803 as it meets the criteria for a serious injury and/or product malfunction.

• Brand Name: DREAMSTATION AUTO CPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 25668876
• Report Number: 2518422-2026-028291
• Device Sequence Number: 21434255
• Product Code: BZD
• UDI-Device Identifier: 00606959424159
• UDI-Public: 00606959424159
• 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: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: Other
• Device Model Number: DSX500H11
• Device Catalogue Number: DSX500H11
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2019
• 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-1972-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown