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

Model Number 3100A

Device Problems Fire (1245); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Results of investigation: a carefusion field service representative (fsr) evaluated the device onsite.The fsr found the cable loose on the driver displacement indicator (ddi) board and secured the cable to the ddi board.The fsr calibrated the ddi board and ran the performance check.The unit passed all tests and meets manufacturer's specifications.

Event Description

The customer reported that while in use on a patient, the ventilator made a loud noise, started shaking, and then the user smelled "smoke".The ventilator was swapped out for another unit and there was no patient harm associated with the reported issue.

Manufacturer Narrative

Corrected data: updated event date to the date received on the customer's medwatch.

Event Description

There was excessive heat coming from the ventilator, noted by touch, and the piston could not be adjusted.When the patient was placed on another ventilator with the same settings, wiggle was noted to be improved and vitals remained stable.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATORY 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: 6291800
• MDR Text Key: 66216723
• Report Number: 2021710-2017-05309
• 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,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/1999
• 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