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

Model Number 3100A

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

Should any additional information be received by the customer then an additional report will be submitted.(b)(4).Device evaluation: a carefusion field service representative (fsr) onsite to the reporter's facility to service the suspect device.No malfunctions were detected and the reported issue was not duplicated.The fsr performed routine preventative maintenance on the device.The unit was tested and calibrated to meet manufacturer specifications.

Event Description

The customer reported that this 3100a hfov (high frequency oscillating ventilator) would give the mean airway pressure greater than 50 cm h2o pressure alarm and dump pressure, intermittently.This occurred while the device was being used on a patient.Alternate ventilation was provided by changing out the unit with a known good unit and the customer stated that there was no patient injury or harm associated with this event.

Manufacturer Narrative

Results of investigation: the carefusion failure analysis laboratory received the 3100 3-ohm driver assembly (that was replaced as part of a preventative maintenance procedure) and evaluated the component.An evaluation of the component could not duplicate the reported issue.There was no failure found with the component.

• 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 ; 7149227830
• MDR Report Key: 5780579
• MDR Text Key: 49124210
• Report Number: 2021710-2016-04030
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

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: 06/10/2016
• Initial Date FDA Received: 07/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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