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

Model Number 3100A

Device Problem Inaccurate Delivery (2339)

Patient Problem No Patient Involvement (2645)

Event Date 04/15/2015

Event Type  malfunction  

Event Description

The customer reported that the ventilator mean airway pressure and the amplitude seems to be fluctuating.No pt involvement.

Manufacturer Narrative

(b)(4).The carefusion field service engineer evaluated the ventilator and found the airway pressure transducer was out of spec on the call and span.Completed vent checkout.All parameters within spec and ventilator ready for pt use.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY / LSZ
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer Contact: wendy schumacher ; 1100 bird center dr.; palm springs, CA 92262 ; 7607787219
• MDR Report Key: 4780960
• MDR Text Key: 5816604
• Report Number: 2021710-2015-00980
• 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: User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/15/2015

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: 3100A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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