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

Model Number	DS560S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A remstar auto a-flex device was returned to a manufacturer service center with no initial alleged complaint.There was no report of serious or permanent harm or injury, and no medical intervention was reported.During evaluation at the manufacturer service center, the device was visually inspected and evidence of foam degradation/particles was observed.Following completion of the evaluation, the device was scrapped by the service center.There was no reported patient involvement, injury, or adverse clinical outcome associated with this event.Based on the identification of foam degradation/particles during device evaluation, this event was determined to be reportable under fda 21 cfr part 803 as a product malfunction and/or potential serious injury event.No additional information is available at this time.

• Brand Name: REMSTAR 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: 25668868
• Report Number: 2518422-2026-028163
• Device Sequence Number: 10406990
• Product Code: BZD
• UDI-Device Identifier: 00606959005884
• UDI-Public: 00606959005884
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K113068
• 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: DS560S
• Device Catalogue Number: DS560S
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2015
• 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