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

Model Number R1111177

Device Problems Circuit Failure (1089); Moisture Damage (1405)

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

Event Date 02/28/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging a bipap a40 system silver ventilator inoperative "low circuit leak" alarm occurred.Water came out of the tube while the alarm was sounding.The device functioned properly afterwards.It was assumed that the device became inoperative because water accumulated within the circuit.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was confirmed.Water ingress was observed within the device.Error code e-20, e- 66 and e-86 was recorded in the event log.The device's main board, blower assembly, outlet flow path and right-side assembly needs to be replaced to address the issues.The device was returned unrepaired due to no response from the patient.

• 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: 18901658
• MDR Text Key: 337630849
• Report Number: 2518422-2024-13827
• 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: 02/28/2021
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1