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

Model Number CAX3100S12

Device Problems Electrical /Electronic Property Problem (1198); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event Description

The manufacturer received information alleging a ventilator inoperative condition occurred and an internal pressure regulation issue.There was no harm or injury reported.The device has not been returned to the manufacturer.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.

Manufacturer Narrative

The manufacturer previously reported receiving information alleging a ventilator inoperative condition occurred and an internal pressure regulation issue.There was no harm or injury reported.The device was evaluated by the manufacturer's product investigation laboratory (pil) and found the device functioned as designed and operated without issue or error codes.

• Brand Name: BIPAP A40 PRO
• Type of Device: VENTILATOR,CONTINUOUS,MINIMAL VENTILATOR SUPPORT, FACILITY USE
• 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: 18509643
• MDR Text Key: 332982716
• Report Number: 2518422-2024-02378
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00606959059405
• UDI-Public: 00606959059405
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Operator: Other
• Device Model Number: CAX3100S12
• Device Catalogue Number: CAX3100S12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/14/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1