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

Model Number 3100A

Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Results of investigation: a carefusion field service representative (fsr) evaluated the device onsite.The fsr found the driver displacement indicator (ddi) out of adjustment.The fsr calibrated the unit per the 2k preventative maintenance procedure and verified performance.The unit passed all performance checks.It was noted by technical support that the customer's reported settings being used on the patient were high, which would have contributed to the device building up excessive heat during prolonged operation.

Event Description

The customer reported that the user noticed that the driver displacement indicator (ddi) was drifting off center.The user tried to recenter the piston and noticed that the amplitude dropped after they recentered the piston so the user had to increase the power setting.The overheat light came on and the user quickly switched the patient to another ventilator.There was no patient compromise associated with the reported issue.

• 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: 6309662
• MDR Text Key: 66762089
• Report Number: 2021710-2017-05335
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2017

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: 01/09/2017
• Initial Date FDA Received: 02/07/2017
• 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): Required Intervention