MAUDE Adverse Event Report: CAREFUSION 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

Model Number 3100A

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

The customer reported that he had just turned off the ventilator after testing it when all of a sudden, he heard a "hissing noise" and then smoke started coming from the vent (middle).The unit was still plugged in to wall ac, but the vent was powered off.It lasted only a few minutes.He could not tell where the smoke was originating from, but when he removed the back column, he noticed black smoke residue along the top portion of the column.No pt involvement.

Manufacturer Narrative

The customer evaluated the ventilator to see if he can find the origin of the smoke.Carefusion will evaluate the alleged failed part if it is returned to the manufacturer.

Manufacturer Narrative

Carefusion's failure analysis laboratory (fa lab) received two suspect components for evaluation.The first component was the power driver module but it was received with electrostatic discharge protection, so the device was unable to be evaluated.The second component was the power cable sub-assembly and visual inspection identified a capacitor was burnt out, confirming the reported issue.The fa lab was unable to determine a root cause of the reported issue due to lack of material to find the cause of the blown capacitor but is being considered to be related to material fatigue.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 4749065
• MDR Text Key: 20718735
• Report Number: 2021710-2015-00895
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2015

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
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 05/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2004
• 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