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

Model Number 3100A

Device Problem Inaccurate Delivery (2339)

Patient Problem No Patient Involvement (2645)

Event Date 06/25/2015

Event Type  malfunction  

Event Description

The customer reported that he was training on this unit & noticed some issues.He said that the limit and adjust needle valves seem to be intermittently in specs.He said at one point the limit needle valve was high at 12.2cm then jumped down to 8.34cm.Then he said the adjust is out of specs reading over 12cm.He said that he has tried another circuit as well & same issues.He also did the pneumatics calibration and all the bulkhead pressures seem fine.No patient involvement, this is a rental unit that hill-rom is checking out/training with.

Manufacturer Narrative

(b)(4).The third party service company evaluated the device & replaced the needle valves to fix the reported issue.The carefusion failure analysis tech will evaluated the alleged failed part if it is returned to the manufacturer.

Manufacturer Narrative

Results of investigation: the suspect needle valve assemblies were returned to carefusion's failure analysis laboratory.An investigation was performed; however, the reported issue could not be duplicated.The unit operated for several hours with no problems.

• 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 pkwy; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 4942332
• MDR Text Key: 15913987
• Report Number: 2021710-2015-01251
• 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: Distributor,distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2015

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-RNT
• Other Device ID Number: UDI #10846446005394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 07/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/1995
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1