MAUDE Adverse Event Report: Respironics, Inc. REMstar System One 60 Series; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	CA461TS
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A remstar procflex+ device was returned to a 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 service center, the device was visually inspected, and no evidence of foam degradation/particles was found.Additionally, a burn was noted, and the power connector was destroyed.The device was scrapped by the service center after the evaluation was completed.
Additional Manufacturer Narrative
The device mentioned in this complaint has exceeded its useful life per the applicable ifu.The reported failure of thermal issue is accommodated in the product risk management file as being linked to hazard with description fire, flame, smoke.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no further indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.

• Brand Name: REMstar System One 60 Series
• 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 ; +1(724)733-0200
• MDR Report Key: 50461980
• Report Number: 2518422-2026-043914
• Device Sequence Number: 18691588
• Product Code: BZD
• UDI-Device Identifier: 00606959014091
• UDI-Public: (01)00606959014091
• 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,Foreign
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: CA461TS
• Device Catalogue Number: CA461TS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2014
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown