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

Model Number	CN1167HS
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Codes	Cyanosis (1798); Dyspnea (1816); Pallor (2468); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : not returned to manufacturer.
Event or Problem Description
The manufacturer received information alleging a bipap avaps c-series device was not operating properly and the host does not run when the non-invasive ventilator is turned on.The patient symptoms include, "clear, mentally poor, shortness of breath, and cyanosis of the lips, breathing 26/min, spo2 88%,." 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 alleging a bipap avaps c-series device was not operating properly and the host does not run when the non-invasive ventilator is turned on.The patient symptoms include, "clear, mentally poor, shortness of breath, and cyanosis of the lips, breathing 26/min, spo2 88%,." the manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.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 AVAPS 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17241871
• Report Number: 2518422-2023-14634
• Device Sequence Number: 20032719
• Product Code: MNS
• UDI-Device Identifier: 00606959015777
• UDI-Public: 00606959015777
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: Health Professional
• Device Model Number: CN1167HS
• Device Catalogue Number: CN1167HS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown