MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number	BLX3100S19
Medical Device Problem Codes	Circuit Failure (1089); Mechanical Problem (1384); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator would stop spontaneously.There was no harm or injury reported.The device has yet to be returned to the manufacturer for evaluation.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported a ventilator would stop spontaneously.There was no harm or injury reported.During the evaluation of the device at the third-party service center, a ventilator inoperative alarm condition indicating a pressure sensor reading issue was observed.The device's main pca board was replaced, and the device's manifold was adjusted to correct the issue.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.This issue has been identified under the fsn 2023-cc-src-039.Additionally, not related to the above issue, the device's airpath assembly was replaced preventatively.The device was tested and passed all testing.The device was scrapped.The bipap a40 pro (blx3100s19) is substantially similar to the bipap a40 (1111169) and will be reported in the united states under bipap a40, 501k number: k121623.

• Brand Name: BIPAP A40
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• 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: 20353918
• Report Number: 2518422-2024-101415
• Device Sequence Number: 6517644
• Product Code: MNT
• UDI-Device Identifier: 00606959059122
• UDI-Public: (01)00606959059122
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: BLX3100S19
• Device Catalogue Number: BLX3100S19
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 08/28/2025
• 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
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1813-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown