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

Model Number 3100A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Carefusion complaint number (b)(4).A carefusion field service representative (fsr) evaluated the device onsite.The fsr found a failure tag attached to 3100a ventilator stating that the user had experienced fluctuating mean airway pressure and a loud noise.The fsr was able to successfully pressurize the unit and run the ventilator with the initial settings found set on the unit.This was at the threshold of limiting pressure with the limit cap diaphragm and a minimal rotation counterclockwise resulted in limiting from that valve resulting in a loud noise.The fsr performed the patient circuit calibration and the performance test.The paw was observed to be very stable.The fsr demonstrated to the customer that the reported noise results from allowing the pressure to be controlled by the limit cap diaphragm and the settings that were being utilized.In the event that additional information is received, a follow-up report will be submitted.

Event Description

The customer initially reported that the ventilator was making a loud noise while the unit was running on a patient.The customer does not know where the noise was coming from, but reported that the unit was working properly otherwise.The customer swapped out the unit due to the noise.It was later reported that along with the noise, fluctuating mean airway pressure was also occurring.There was no patient compromise 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: 6155670
• MDR Text Key: 61805497
• Report Number: 2021710-2016-05000
• 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: 12/08/2016

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: 11/08/2016
• Initial Date FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2009
• 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