MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 SYSTEM SILVER; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number R1111177

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Dyspnea (1816); Anxiety (2328); Sleep Dysfunction (2517); Unspecified Respiratory Problem (4464)

Event Date 10/23/2017

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator inoperative condition occurred.The patient alleged difficulty breathing, uneasiness and trouble sleeping.There was no patient intervention reported.The manufacturer received the device for evaluation.A review of the error logs identified an error occurred.The main board was replaced to address to the issue.In addition, the blower, outlet flow path, and inlet foam kit were replaced unrelated to the reportable malfunction.

• Brand Name: BIPAP A40 SYSTEM SILVER
• Type of Device: VENTILATOR, CONTINUOUS, 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18136794
• MDR Text Key: 328126874
• Report Number: 2518422-2023-30194
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,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 Operator: Lay User/Patient
• Device Model Number: R1111177
• Device Catalogue Number: R1111177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female