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

Model Number ITX3100S21

Device Problem Circuit Failure (1089)

Patient Problem Insufficient Information (4580)

Event Date 09/14/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.The device evaluation has not begun.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.

• Brand Name: BIPAP A40 PRO
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19038899
• MDR Text Key: 339325570
• Report Number: 2518422-2024-17237
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial

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: ITX3100S21
• Device Catalogue Number: ITX3100S21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1