MAUDE Adverse Event Report: CAREFUSION CAREFUSION; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number AVEA

Device Problems Erratic or Intermittent Display (1182); Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2015

Event Type  malfunction  

Event Description

The customer called carefusion tech support stating that the exhalation valve on one of their units was "sticking, and very inconsistent".This occurred while the unit was being tested for performance, before use.No patient involvement.

Manufacturer Narrative

(b)(4).A carefusion fsr evaluated the unit and observed the following: what the customer was actually seeing was that expiratory would not return to baseline.He observed that the expiratory pressure xdcr zero had drifted 200 a/d counts.The expiratory pressure xdcr had failed.He determined the root cause of this issue was a faulty gas delivery engine.The service rep replaced the gas delivery engine and reset the serial number and model configuration.He performed operational checks, and found that the unit was operating per mfr specifications.The repaired unit was returned to the customer.A returned goods authorization (rga) number was issued for the return of the faulty gas delivery engine.The faulty gas delivery engine was returned to carefusion failure analysis lab for evaluation on (b)(6) 2015, however it has not been evaluated.Once the faulty gas delivery engine is evaluated, a f/u medwatch report will be submitted.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer Contact: jacquiline tamale ; 1100 bird center dr.; palm springs, CA 92262 ; 7607787234
• MDR Report Key: 4568398
• MDR Text Key: 15313525
• Report Number: 2021710-2015-00401
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 01/28/2015

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: AVEA
• Device Catalogue Number: 17210-00
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2004
• 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