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

Model Number 1111169

Device Problems Electrical /Electronic Property Problem (1198); Device Emits Odor (1425)

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

Event Date 10/17/2019

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator alarming error code and giving off an electrical odor.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center the error code was confirmed.No service action was required for the error code.The electrical odor fault was not confirmed but the odor was caused by tar and nicotine.The blower was contaminated with tar and the flow path was yellowing which was caused by the nicotine.The unit was scrapped.

Manufacturer Narrative

H3 other text : serviced by third party service center.

• Brand Name: BIPAP A40, INTERNATIONAL
• 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: 18246252
• MDR Text Key: 329482815
• Report Number: 2518422-2023-32769
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1111169
• Device Catalogue Number: 1111169
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1