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

Model Number	565P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A remstar auto a-flex device was returned to a third-party service center as part of the uno recall process with no initial alleged complaint.During the evaluation of the device, the service technician observed damaged foam particles.The device was scrapped by the service center after the evaluation was completed.

• 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: 23624037
• Report Number: 2518422-2025-111998
• Device Sequence Number: 9031890
• Product Code: BZD
• UDI-Device Identifier: 00606959037915
• UDI-Public: (01)00606959037915
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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): 11/22/2025

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: 565P
• Device Catalogue Number: 565P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2016
• 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
• Usage of Device: Reuse
• 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