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

Model Number FRX3100S14

Device Problem Unexpected Shutdown (4019)

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

Event Date 04/24/2024

Event Type  malfunction  

Event Description

The manufacturer received information alleging a high oxygen concentration alarm.There was no harm or injury reported.The ventilator was returned to the manufacturer's product investigation lab (pil) and during evaluation of the device, ventilator inoperative alarms were found in the ventilator's error log.It is suspected that the device had a faulty o2 sensor on the main board.A failure of the sensor would not impact therapy.The ventilator inoperative alarms were due to a stuck blower.Determination made that the unit will be scrapped.The bipap a40 pro is substantially similar to the bipap a40 and will be reported in the united states under bipap a40 pro, 501k number: k121623.

• Brand Name: BIPAP A40 PRO
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19191824
• MDR Text Key: 341155399
• Report Number: 2518422-2024-22768
• 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: 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: FRX3100S14
• Device Catalogue Number: FRX3100S14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2024
• Initial Date Manufacturer Received: 04/24/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1