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

Model Number 1111175

Device Problem Noise, Audible (3273)

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

Event Date 06/18/2018

Event Type  malfunction  

Event Description

During the evaluation of the bipap a40 at the manufacturer's service center, it was confirmed that the device did not meet criteria of evaluation process for: error code e-46 blower is noisy, water degradation, blower assembly, blower cap, blower housing, internal air cover, internal foam, blower box mount, right panel assembly and pollen filter needs to be replaced.There was no harm or injury reported.The estimate was rejected, and the device was scrapped.

• Brand Name: BIPAP A40
• 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: 18300583
• MDR Text Key: 330162950
• Report Number: 2518422-2023-34652
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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: Other
• Device Model Number: 1111175
• Device Catalogue Number: 1111175
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1