MAUDE Adverse Event Report: CAREFUSION SENSORMEDICS; VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problems Moisture Damage (1405); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/03/2014

Event Type  malfunction  

Event Description

Two sensormedics high frequency ventilators (models 3100a and 3100b) have failed in use in recent months.The investigation found water ingress into the proximal airway line which caused the pressure sensors to fail.I have comments from the manufacturer that contradict each other and pictures of the internal circuit of the machine if required.Manufacturer's response: technical support #1: "water ingress frequently occurs on the 3100b because it uses a shorter circuit.Dependent on patient y position." technical support #2 (from manual): "a trickle flow of dry gas from the blender flows constantly from the 3100b to the patient y to keep water vapor from even partially obstructing this pressure sensing pathway".

• Brand Name: SENSORMEDICS
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 3820043
• MDR Text Key: 17987444
• Report Number: 3820043
• Device Sequence Number: 1
• Product Code: LSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/28/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3100A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2014
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2014
• Patient Sequence Number: 1