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

Model Number 3100A

Device Problems Fire (1245); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer replaced several components and returned them to carefusion for further investigation.Investigation is currently pending.Once the investigation results are complete, a supplemental report will be submitted.

Event Description

The customer reported that the black capacitor on the power cord spontaneously caught on fire when plugged into a universal power supply.The ventilator was not turned on when it was being plugged in.There was no patient involvement associated with the reported issue.

Manufacturer Narrative

Device evaluation: results of investigation: the carefusion failure analysis laboratory received the suspect components, a 3100a driver and 3100a power cable assembly, and evaluated the device.An evaluation of the 3100a driver did not duplicate the reported issue.An evaluation of the 3100a power cable assembly verified that the black capacitor on the power cord is burned.The component had been burned and damaged, therefore, the complaint reported issue could not be duplicated.

Manufacturer Narrative

(b)(4).The customer initially reported that there was no patient involvement.Upon follow up with the customer for additional information, they reported that the device was operating on a patient at the time.

Event Description

The ventilator was in use on a patient when the reported issue occurred.The unit was immediately swapped out and there was no patient harm or injury associated with the reported 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: 6201474
• MDR Text Key: 63480883
• Report Number: 2021710-2016-05101
• 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,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2017

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: 12/20/2016
• 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: Not provided; Not provided
• Supplement Dates FDA Received: 01/24/2017; 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Required Intervention