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

Model Number R1111177

Device Problems Electrical /Electronic Property Problem (1198); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/25/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging that a patient's ventilator flow stopped for a couple of seconds then restarted.It was reported that the sp02 decreased to 89 and that the device was functioning properly after the event.When the sales representative arrived at the home, the sp02 was continuously around 91.The device was replaced, and the patient was suctioned.It was reported that the sp02 post suctioning and replacement was back to normal.Two hours later, it was reported that the saturation decreased to 89.Family reported that it was less likely that the device was faulty.The nurse determined that the sp02 decreased because of phlegm.The family consulted a family doctor and determined that the event was caused by the patient's condition.Other than suctioning the patient, no other medical intervention was reported.During the evaluation of the device at the manufacturer's service center, a ventilator inoperative event was confirmed in the error log.The device's blower was replaced to address the issue.Additionally, they replaced the outlet flow path due to a life related smell.Also, the inlet foam kit will be replaced when foam kit stock replenishes.

• Brand Name: BIPAP A40 SYSTEM SILVER
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, 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: 18020095
• MDR Text Key: 326697388
• Report Number: 2518422-2023-27908
• 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: 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?: Yes
• 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: 10/17/2022
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 68 YR
• Patient Sex: Female