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

Model Number 3100A

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Carefusion will evaluate the alleged failed product if it is returned to the manufacturer.(b)(4).

Event Description

The customer reported that the hz is not adjusting at this time and it seems to be stuck at 1.4 hz.He also stated that the map is holding pressure at 32cm, when he depresses the start/stop button the driver won't start either.No patient involvement.

Manufacturer Narrative

The (b)(6) examined the driver power module and found that it is functioning normally.Installed power driver module into a known good 3100a test unit and found that it functions normally and that the frequency can be adjusted from 2.7 hz to 15.2 hz.Operated unit for 2.5 hours.Per, 3100a high frequency oscillatory ventilator service manual.Also found that this driver power module causes the driver in this test unit to operate normally.Could not duplicate, power driver module frequency is stuck at 1.4 hz or power driver module does not operate, complaint allegation.Examined the driver that was returned by the customer and found that it is functioning normally.Installed driver into a known good 3100a test unit, set the unit to the standard settings, operated unit for 18 hours and found no problems.Installed 3100a driver power module into test unit so that, both returned components were in the test unit together, operated unit for 2 hours and found no problems.Unit was turned on and off multiple times and the driver started every time without any problems.Could not duplicate, driver won't start, complaint allegation.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 75 n. fairway drive; vernon hills, IL ; 8473628056
• MDR Report Key: 5062070
• MDR Text Key: 25416519
• Report Number: 2021710-2015-01583
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Report Date: 08/11/2015

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2009
• 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