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 11/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A carefusion field service representative (fsr) evaluated the device onsite.The ventilator was due for the 12k preventative maintenance.The fsr replaced the driver and installed the 12k preventative maintenance kit.The fsr installed a new circuit calibration label and a new 9 volt battery.The unit is operating to specification and is ready to be placed into service.The 3-ohm driver assembly was returned to the carefusion failure analysis laboratory.Upon completion of the device investigation, a follow-up report will be submitted.

Event Description

The customer reported that the mean airway pressure (map) was set at 17 and was fluctuating between 15 and 20, while the device was in use on a patient.The customer replaced the circuit and changed out the cap diaphragms, but this did not resolve the issue.The patient was removed from the ventilator and placed on another unit.There was no patient harm.The customer reported evaluating the ventilator after the incident and could not duplicate the issue.The ventilator passed the patient circuit calibration and performance check and the map was steady.

Manufacturer Narrative

The vyaire medical failure analysis laboratory received the suspect component, a 3100a 3-ohm driver assembly, and evaluated the device.An evaluation of the component did not duplicate the reported issue.There were no fluctuations observed in the mean airway pressure (map).The map remained stable.

• 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: 6201475
• MDR Text Key: 63172737
• Report Number: 2021710-2016-05100
• 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,Followup
• Report Date: 09/22/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: 09/14/2017
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/1999
• 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