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 No Consequences Or Impact To Patient (2199)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Carefusion complaint number (b)(4).A carefusion field service representative (fsr) evaluated the device onsite.The fsr was unable to duplicate the reported issue.The fsr found the pressure regulator 3 was stripped.The unit was due for the 7 year preventative maintenance.The fsr performed the 7 year preventative maintenance and the 500 hour preventative maintenance.The fsr installed the driver power module.The fsr performed the operational verification procedure and the unit meets manufacturer's specifications.

Event Description

The customer reported that the mean airway pressure (map) was dropping while the device was in use on a patient.The user replaced the patient's breathing tubing numerous times, but the issue was not resolved.The patient was switched to another unit and there was no patient harm.The customer replaced pressure regulator 7, but the issue was not resolved.The customer performed the patient circuit calibration and the performance check onthe unit and the unit passed both tests.The customer was not able 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: 6210835
• MDR Text Key: 63440143
• Report Number: 2021710-2016-05116
• 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: 12/28/2016

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: 11/29/2016
• Initial Date FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2007
• 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