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

Model Number 3100A

Device Problem Inaccurate Delivery (2339)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

The carefusion product manager and the carefusion technical support specialist verified the reported scenario with both the old and new cap diaphragms.Although it can occur with both types of cap diaphragms, the new cap diaphragms took a couple of liters per minute of flow to create the scenario (2-3 lpm of flow instead of 0 bias flow).

Event Description

The customer reported an issue found with the new style cap diaphragms where the ventilator continues oscillate with no flow using new cap and diaphragms.While running the 3100a using the new improved cap/diaphragms, it is possible to reduce the limit and map adjustment knobs all the way ccw.Unit still oscillates at 10 cmh2o map.The flow can then be adjusted all the way to zero, and the unit still oscillates at 8 cmh2o without any bias flow.No patient involvement.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 75 n.fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4976122
• MDR Text Key: 22419576
• Report Number: 2021710-2015-01294
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 07/10/2015

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: 3100A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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