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

Model Number	DS560TBT
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A remstarauto 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, the third-party service center visually inspected the device and observed visible foam particles inside the blower kit and noted a blower foam degradation.Additionally, the service technician also noted dust contamination, and the evaluation of the device data identified unrelated error codes.These error codes are consistent with normal device operation and expected use condition that are not considered reportable under medical device reporting requirements.No evidence was identified to suggest that these error codes contributed to or caused the reported event.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.
Additional Manufacturer Narrative
A follow-up is necessary due to an incorrect event description and the component code must be mechanical/ insulation.
Event or Problem Description
A remstarauto 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, the third party service center visually inspected the device and observed visible foam particles inside the blower kit and noted a blower foam degradation.Additionally, the service technician also noted dust contamination, and the evaluation of the device data identified unrelated error codes.These error codes are consistent with normal device operation and expected use condition that are not considered reportable under medical device reporting requirements.No evidence was identified to suggest that these error codes contributed to or caused the reported event.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: 24282732
• Report Number: 2518422-2026-004343
• Device Sequence Number: 8289841
• Product Code: BZD
• UDI-Device Identifier: 00606959030510
• UDI-Public: (01)00606959030510
• 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
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: DS560TBT
• Device Catalogue Number: DS560TBT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2015
• 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