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

Model Number 3100A

Device Problems Device Alarm System (1012); Calibration Error (1078); Loss of Power (1475); Pressure Problem (3012)

Patient Problem No Information (3190)

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.Upon completion the unit was returned to the customer¿s control ready to be placed back into service.

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.(b)(4) was on a patient (settings unknown) and suddenly the driver stopped.They quickly responded to the vent alarms and hand bagged 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 then went to get another 3100a set up.Unfortunately, they could not get tma31694 to pass the patient circuit calibration.They obtained a third 3100a (b)(4) and it passed the patient circuit calibration and performance check.The patient was placed on this vent and was doing fine until 3 hours later.The doctors were at the bedside changing settings and felt that they should be getting more amplitude out of this vent.Because of the issues with the last two ventilators, the doctors felt uncomfortable using (b)(4).They put the patient on a conventional ventilator.Risk management then sequestered the vents.

• 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 ; 7607787307
• MDR Report Key: 5412645
• MDR Text Key: 38133217
• Report Number: 2021710-2016-02842
• 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

• Date FDA Received: 02/05/2016
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2004
• 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