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

Model Number	CA561HBT
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A remstar auto a flex device was returned to a third party service center for service as part of the sound abatement foam recall process with no initial alleged complaint.During the evaluation of the device at the third party service center the foam particles were found inside the blower kit and blower foam degradation was noted.Additionally, the service technician observed error e33 err_comp_log_sem_timeout on the device log and a dirt contamination was present.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.; 6501 living place; pittsburgh PA
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 24078038
• Report Number: 2518422-2026-002106
• Device Sequence Number: 5816591
• Product Code: BZD
• UDI-Device Identifier: 00606959030565
• UDI-Public: (01)00606959030565
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

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: CA561HBT
• Device Catalogue Number: CA561HBT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2015
• 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