MAUDE Adverse Event Report: CAREFUSION 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problems Use of Incorrect Control/Treatment Settings (1126); Device Operates Differently Than Expected (2913)

Patient Problem Respiratory Acidosis (2482)

Event Date 01/09/2016

Event Type  Injury  

Manufacturer Narrative

The ventilator was not returned to carefusion.A carefusion field service engineer (fse) was dispatched to evaluate the unit.The fse found evidence of use error during his evaluation - the limit setting was at or below the adjust setting which reduced the flow of fresh gas past the patient wye fitting.The fse verified ventilator performance and did not find evidence of a malfunction.Any additional information received will be evaluated and included in a follow-up report if required.(b)(4).

Event Description

A customer reported to carefusion that a patient exhibited "very little" chest wiggle while on a 3100 high frequency oscillating ventilator (hfov) and carbon dioxide (co2) was elevated.The customer was unable to resolve the co2 and chest wiggle problems and found it necessary to remove the patient and place the patient on another 3100 hfov.The customer manually ventilated the baby during the ventilator exchange and the chest wiggle was improved after switching ventilators.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• 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: jill rittorno ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5420512
• MDR Text Key: 37931556
• Report Number: 2021710-2016-03079
• 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,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 01/11/2016

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: 01/11/2016
• Initial Date FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention