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

Model Number	1067P
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Dyspnea (1816); Confusion/ Disorientation (2553); Blood Bicarbonate Increased (4826); Sleepiness/Drowsiness/Somnolence (4850)
Date of Event	03/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information regarding a bipap s/t c-series device.A healthcare facility reported that the device went into automatic power off about a half an hour into use.There is an allegation that the patient's dyspnea worsened, experienced confusion and drowsiness, and the pco2 was reading high.Pulmonary encephalopathy was considered, and the non-invasive ventilator was immediately switched.The patient's consciousness gradually recovered, and he was conscious.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP ST
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 21673407
• Report Number: 2518422-2025-103308
• Device Sequence Number: 8035641
• Product Code: MNS
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: Lay User/Patient
• Device Model Number: 1067P
• Device Catalogue Number: 1067P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2025
• Supplement Report FDA Received Date: 09/22/2026
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown