MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP V30 AUTO; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1111178
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to the manufacturer by a distributor that the bipap v30 auto device ceased functioning during active therapy on a patient in the hospital/user facility.The patient was admitted with acute on chronic hypoxic and hypercapnic respiratory failure and was placed on the bipap v30 auto at settings of s/t 10/5 cmh2o with 6 l/min oxygen bleed-in at approximately 00:58.About one hour after therapy initiation, the device shut off and displayed a ¿ventilator inoperative¿ condition.Based on available information, the device entered an inoperative condition during use, resulting in a ventilation interruption.This contributed to patient desaturation and subsequent hypercapnia requiring intubation.The event has been assessed as a serious injury per 21 cfr 803.3(w).The device cause/contribution to the event is confirmed.The device has not been returned to the manufacturer and is currently awaiting evaluation.Should the device be received and evaluated, a follow-up report will be submitted to provide the investigation results.
Additional Manufacturer Narrative
It was previously reported by a distributor that a bipap v30 auto ventilator ceased functioning during active therapy on a hospitalized patient, displaying a "ventilator inoperative" condition approximately one hour after therapy initiation.The ventilation interruption was reported to contribute to patient desaturation and hypercapnia, requiring intubation.The device was returned for evaluation by the manufacturer's lab.Review of the device error log identified one instance of an error, which indicates the device rebooted three times within a 24-hour period and can generate a ventilator inoperative condition.Additional evaluation included operation of the device on an asl lung simulator, during which no unexpected errors or ventilator inoperative conditions were observed.No components were replaced, no definitive root cause was identified, and no new findings were identified that would impact the device risk analysis.The evaluation is complete, and this submission represents a follow-up final mdr providing the investigation results.

• Brand Name: BIPAP V30 AUTO
• 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 ; 7247330200
• MDR Report Key: 23507282
• Report Number: 2518422-2025-111669
• Device Sequence Number: 18397365
• Product Code: MNS
• UDI-Device Identifier: 00606959067936
• UDI-Public: (01)00606959067936
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K113053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: Health Professional
• Device Model Number: 1111178
• Device Catalogue Number: 1111178
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 11/09/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1812-2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown