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

Model Number 3100B

Device Problems Sticking (1597); Pressure Problem (3012)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2014

Event Type  malfunction  

Manufacturer Narrative

A carefusion fse went onsite and installed a pr3 and the system pressurized correctly.The fse also installed a needle valve assembly.All is ok now.As of this date the parts have not been received for evaluation.When it has been received and evaluated a supplement will be filed.

Event Description

The following description of the event was documented by a carefusion tech support specialist in a response to a phone conversation with a user facility representative on (b)(6) 2014 the customer called to report that they can't get any pressure out of this vent.They also report that the adjust knob doesn't seem to move like it should.The customer also stated there was no patient involvement in this issue.

• 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: marshall thompson ; 7607787307
• MDR Report Key: 5415312
• MDR Text Key: 38158345
• Report Number: 2021710-2016-02924
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100B
• Device Catalogue Number: 770155
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2004
• Type of Device Usage: Reuse
• Patient Sequence Number: 1