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

Model Number 3100A

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2015

Event Type  malfunction  

Event Description

The customer reported that while in pt use the limit knob would adjust the mean airway pressure (map) from 11 to 14 without much effort but the adjust knob would not adjust the may up or down.Map initially set between 11 and 12, power set to 2.5 (b)(4).The pt was removed from the ventilator and placed on another ventilator, no pt harm.

Manufacturer Narrative

The carefusion field service engineer evaluated the ventilator and was not able to duplicate the reported issue.Educated the customer the process of how to set the limit and adjustment settings.Customer was using a method of simultaneously rotating the limit and adjust knobs to set the limit value.Advised the method works but could create a margin of error if the knobs are not carefully set.Suggested to set the limit first with the adjust knob set to max, then adjust the adjust knob to achieve the desired operating map.Completed alarms checkout.All system performing to specification on the ventilator.

• Brand Name: CAREFUSION
• Type of Device: VENTILATOR, HIGH FREQUENCY/LSZ
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: wendy schumacher ; 7607787219
• MDR Report Key: 4804415
• MDR Text Key: 16559570
• Report Number: 2021710-2015-01046
• 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: Other
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 768901-103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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
• Patient Outcome(s): Required Intervention