MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP S/T C SERIES; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	CN1067HS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2023
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a patient with a bipap s/t c series core package device has passed away.There was no allegation that the device contributed to the death.Additional information has been requested regarding the details of the reported death.
Additional Manufacturer Narrative
The manufacturer previously received information alleging a patient with a bipap s/t c series core package device has passed away.There was no allegation that the device contributed to the death.Additional information has been requested regarding the details of the reported death.Previously submitted report was incorrectly filed with wrong health impact grid.In this report, box h: health impact grid (1) has been updated and corrected.

• Brand Name: BIPAP S/T C SERIES
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 22642431
• Report Number: 2518422-2025-048389
• Device Sequence Number: 12931084
• Product Code: BZD
• UDI-Device Identifier: 00606959015753
• UDI-Public: (01)00606959015753
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: CN1067HS
• Device Catalogue Number: CN1067HS
• 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: 05/26/2023
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2020
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown