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

Model Number 1111177

Device Problem Failure to Calibrate (2440)

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

Event Date 10/18/2023

Event Type  malfunction  

Event Description

The device was returned to the manufacturer in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.There was no allegation of device malfunction.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, a failure occurred on functional testing.The device's main board was replaced to address the issue.Damage was seen to the top enclosure and ui panel.Therefore, the top enclosure and ui panel were replaced.The device was visually inspected and confirmed that there was no peeling or deterioration of the foam.Replaced rp-airpath kit, a30, a40, v30, ola+ p/n 1152388 per lbl1155427.Performed functional test of the device per bipap a30 & bipap a40 original and silver series manual, and the device passed it successfully.Software version was upgraded to 3.6.5.

• Brand Name: BIPAP A40
• 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: 18038975
• MDR Text Key: 326967213
• Report Number: 2518422-2023-28080
• 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,Company Representative
• 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: 1111177
• Device Catalogue Number: 1111177
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1