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

Model Number R1111177

Device Problems Pressure Problem (3012); Unexpected Shutdown (4019)

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

Event Date 02/06/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging a bipap a40 system silver ventilator "pressure regulation" alarm frequently occurred.The sales rep checked the device at the user facility and the device temporarily quit providing a flow due to rebooting.There was no harm or injury reported.The ventilator was returned to the manufacturer for periodic maintenance and evaluation and the customer¿s complaint was not confirmed.The device had no malfunction but, the blower was replaced to prevent failure.Error code e150, (reboot) e-116 (pressure regulation) and e-96 with a date of 1970 was recorded in the event log.The device's main board was replaced to address the issue.In addition a life-related smell was observed so the following parts were replaced: outlet flow path, right side assembly, top enclosure, ui panel.A a40 silver inlet foam kit will be replaced when the replacement part arrives.

• Brand Name: BIPAP A40
• 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: 18910942
• MDR Text Key: 337730894
• Report Number: 2518422-2024-13964
• 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,User Facility
• 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: Health Professional
• 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: 02/06/2023
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1