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

Model Number	1067P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	05/20/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The exact year of event/death was not available at the time of this report.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.H3 other text : device not returned to the manufacturer.
Event or Problem Description
The manufacturer received information stating a death occurred while a bipap s/t c series ventilator was in use by a patient.The family member reported that on (b)(6), there was no abnormal alarm while the device was in use.The power was cut off between 2:09am to 2:38am on (b)(6) and the system was shut down.The family member states after the power were restored, the patient was found dead at 5am due to the patient's inability to move to turn the treatment button back on.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported: the manufacturer received information stating a death occurred while a bipap s/t c series ventilator was in use by a patient.The family member reported that on may 19, there was no abnormal alarm while the device was in use.The power was cut off between 2:09am to 2:38am on may 20 and the system was shut down.The family member states after the power were restored, the patient was found dead at 5am due to the patient's inability to move to turn the treatment button back on.The exact year of event/death was not available at the time of this report.New information: additional information regarding the date of death and event date was added to section b.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported receiving information stating a death occurred while a bipap s/t c series ventilator was in use by a patient.The family member reported that on may 19, there was no abnormal alarm while the device was in use.The power was cut off between 2:09am to 2:38am on may 20 and the system was shut down.The family member states after the power were restored, the patient was found dead at 5am due to the patient's inability to move to turn the treatment button back on.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: BIPAP S/T C SERIES
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 18660277
• Report Number: 2518422-2024-06098
• Device Sequence Number: 7129279
• Product Code: MNS
• UDI-Device Identifier: 00606959039209
• UDI-Public: 00606959039209
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2025

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?: Yes
• Operator of Device: Other
• Device Model Number: 1067P
• Device Catalogue Number: 1067P
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 02/08/2024; 04/21/2025
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 02/08/2024; 11/08/2025
• 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