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

Model Number 3100A

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2014

Event Type  malfunction  

Manufacturer Narrative

This medwatch report was identified as a late submission during a two year retrospective review of complaints and mdr¿s following receipt of an untitled letter issued by the fda.The carefusion fse went onsite and was unable to duplicate the issue.The fse performed the patient circuit calibration and the ventilator performance check.Ran unit for 90 minutes and still no failure noted.All is ok now.

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 while in use the vent stopped oscillating.There was an audible alarm.The patient was placed on a different vent and there was no harm noted to the patient.

• 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: 5415518
• MDR Text Key: 38228120
• Report Number: 2021710-2016-02935
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/17/2014

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: 03/17/2014
• Initial Date FDA Received: 02/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2002
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1