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

Model Number 3100A

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 12/03/2013

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 field service rep.Performed a 2000 hour (unit calibration) preventative maintenance (pm) service which is a complete calibration and checkout to ensure that it meets all factory specifications.The carefusion field service rep.Ran the unit for 18 hours to ensure that there were no additional issues with the unit.

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 9 jan 2014.(b)(4) was on a patient (settings unknown) and suddenly the driver stopped.They quickly responded to the vent alarms and handbagged the patient while they troubleshot the issue.They replaced the cap diaphragms, changed the circuit, checked for leaks and tightened all connections, but they were unable to pressurize and restart the driver.They moved the patient to a different unit.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY / LSZ
• 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
• MDR Report Key: 5411042
• MDR Text Key: 38087278
• Report Number: 2021710-2016-02838
• 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: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/09/2014
• Initial Date FDA Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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
• Patient Outcome(s): Life Threatening