MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 SYSTEM SILVER; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number R1111177

Device Problem Circuit Failure (1089)

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

Event Date 04/07/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging a bipap a40 system silver ventilator inoperative condition occurred.There was no harm or injury reported.The nurse reported that the system rebooted.The ac power disconnected alarm occurred a few times prior to the reboot and a cord was found loose.The reported issue was not confirmed during the evaluation of the device at the manufacturer's service center.Error code e-20, e-95 and e-11 were found in the ventilator's downloaded error log.The device's main pca was replaced to address the issue.It was confirmed that the issue was resolved after the repair.

• Brand Name: BIPAP A40 SYSTEM SILVER
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 18901425
• MDR Text Key: 337619689
• Report Number: 2518422-2024-13824
• 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: Foreign,Health Professional
• Reporter Occupation: Nurse
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1