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

Model Number 3100A

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2016

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 checked the unit with the same settings as the customer reported and could not duplicate the reported issue.The fsr was informed by the customer that it is possible that there was a leak in the circuit that was being used at the time of the event and this could have caused the unit to not pressurize.The fsr evaluated the unit with a new circuit at various settings and no issued were found.The unit is working per manufacturer's specifications.

Event Description

The customer reported that the piston stopped and the customer could not get it to restart, while the device was in use on a patient.The patient was removed from the ventilator and placed on another unit.There was no patient harm.The customer changed the patient circuit and cap diaphragms, but the piston still would not start.The customer was able to perform the patient circuit calibration and performance check on the unit without any issues and 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: 6201473
• MDR Text Key: 63171987
• Report Number: 2021710-2016-05098
• 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: 11/01/2005
• 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