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

Model Number	CA561HS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A remstar auto a flex device was returned to a third party service center with no initial alleged complaint.There was no report of serious or permanent harm or injury.There was no report of medical intervention.During the evaluation of the device at the third party service center, the device was visually inspected, and evidence of foam degradation.Particles were found inside the blower kit.Additionally, the service technician also noted dust contamination.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: REMSTAR AUTO A FLEX
• 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: 24512067
• Report Number: 2518422-2026-007714
• Device Sequence Number: 10415856
• Product Code: BZD
• UDI-Device Identifier: 00606959014145
• UDI-Public: (01)00606959014145
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: CA561HS
• Device Catalogue Number: CA561HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2015
• 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-1974-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown