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

Model Number FRX3100S14

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 07/19/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging a high o2 concentration error had occurred the device.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, an error code related to a ventilation inoperative error was observed.The device has a clogged etched disk creating pressure errors and may have a faulty o2 sensor located on the device.No parts were replaced because the device was scrapped.

Manufacturer Narrative

The bipap a40 pro ((b)(6)) is substantially similar to the bipap a40 ((b)(6)) and will be reported in the united states under bipap a40, 501k number: k121623.

• Brand Name: BIPAP A40 PRO
• Type of Device: VENTILATOR,CONTINUOUS,MINIMAL VENTILATOR 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19168459
• MDR Text Key: 341052643
• Report Number: 2518422-2024-21811
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00606959055100
• UDI-Public: 00606959055100
• 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,Distributor
• 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: FRX3100S14
• Device Catalogue Number: FRX3100S14
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/22/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1