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

Model Number R1111177

Device Problem No Device Output (1435)

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

Event Date 08/29/2018

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator inoperable alarm sounded while the device was in use and the device operation stopped.The patient's mother cycled power on the device.The device rebooted and was returned to use.Approximately three hours later the device was replaced.There was no harm or injury reported.No medical interventions were specified.During the evaluation of the device at the manufacturer's service center, the downloaded error log report confirmed the allegation.The device logged three occurrences of ventilator inoperable errors.The service center observed that only the disconnect alarm was active.The lab determined the cause of the malfunction appears to be a one time liquid intrusion.The liquid entered in such a place that it caused corruption of data exchange between the sensors and cpu.The cpu could not properly ascertain the operating conditions and shut the device down.The pca was run in a similar unit for 45 hours with no repeat of the symptoms.The unit ran extensively.Unable to recreate the fault.The units were scrapped.

• Brand Name: BIPAP A40 SYSTEM
• 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: 18246673
• MDR Text Key: 329487003
• Report Number: 2518422-2023-32939
• 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: Foreign,User Facility
• Reporter Occupation: Other Health Care 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: Health Professional
• Device Model Number: R1111177
• Device Catalogue Number: R1111177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1