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

Model Number R1111177

Device Problems Decrease in Pressure (1490); Unexpected Shutdown (4019)

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

Event Date 04/13/2021

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 patient reported to a sales rep that the device beeped as if the power turned off and at the same time so did the air supply and the device quit working and then restarted power/airflow again.The sales rep could not confirm the occurrence from the alarm or event log.Multiple electrical cords were connected to a single outlet and the patient use a ht humidifier.In addition, the family reported that the pressure turned low.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was not confirmed.Error code e-150 was recorded in the event log, therefore the main board was replaced.Periodic maintenance was performed.The device had no malfunction, but the following parts were replaced to prevent failure, blower: inlet path foam.The device's blower motor was replaced to address the issue.A life like smell was observed, so the outlet flow path was replaced.

• 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: 18903161
• MDR Text Key: 337651770
• Report Number: 2518422-2024-13854
• 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: Non-Healthcare Professional
• 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
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1