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

Model Number 3100A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Abnormal Blood Gases (1034)

Event Date 11/19/2016

Event Type  Injury  

Manufacturer Narrative

Carefusion complaint number (b)(4).(b)(4).Results of investigation: a carefusion field service representative (fsr) evaluated the device onsite.The fsr was presented with the 3100a ventilator with the patient circuit attached.The fsr was able to power up and operate the ventilator with settings reported by the customer.The fsr found the amplitude on the performance check out of specification due to the driver displacement indicator calibration being out.The fsr checked the frequency and % inspiratory time calibrations, driver controller and power module calibrations, and transducer calibrations.The fsr performed the driver displacement calibration.The unit is operating within factory specifications and the fsr was unable to duplicate the reported issue.

Event Description

The customer reported that the power knob was at 9.4, the oscillator overheat light was on, and the customer could not center the piston, while the device was in use on a patient.The customer could smell the unit starting to overheat and the patient had a bad abg result.The patient was switched to another unit.The customer evaluated the unit after the incident and the unit passed the pre-use patient circuit calibration and performance check and the customer was not unable to duplicate the issue.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6201470
• MDR Text Key: 63174149
• Report Number: 2021710-2016-05099
• 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: Health Professional
• Type of Report: Initial
• Report Date: 12/22/2016

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?: 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: 11/23/2016
• Initial Date FDA Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2009
• 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