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

Model Number 3100A

Device Problems Failure to Power Up (1476); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

Carefusion complaint number (b)(4).In the event the device is received for evaluation or additional information is received a follow-up report will be submitted.At this time, carefusion has not received the device from the customer.(b)(4).

Event Description

The customer stated that the start/stop button is not engaging well when pressed and the centering display is only showing 2 leds lit.This occurred during set-up therefore there was no patient involvement.

Manufacturer Narrative

The carefusion field service representative evaluated the unit on (b)(6) 2015 and found the issue to be that the pressure regulator was out of specification.The driver was tested a various settings and no further issues were found.The ventilation was run through the alarms test, the patient circuit calibration test and performance checks and all passed.The ventilator was placed back into service.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149227830
• MDR Report Key: 5338393
• MDR Text Key: 35062510
• Report Number: 2021710-2015-02598
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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