MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PLUS; VENTILATOR, NON-CONTINUOUS (RESPIRA

Model Number	DS260HS
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
A remstar auto device was returned to the service center with no initial alleged complaint.During the evaluation of the device at the third-party service center, the device was visually inspected and j9 connector thermal damage was observed.Additionally, no evidence of foam degradation and j8 connector physically damaged were observed, and the device will be disposed of.

• Brand Name: REMSTAR PLUS
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRA
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 24795810
• Report Number: 2518422-2026-111942
• Device Sequence Number: 9548593
• Product Code: BZD
• UDI-Device Identifier: 00606959005778
• UDI-Public: (01)00606959005778
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

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: DS260HS
• Device Catalogue Number: DS260HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2013
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown