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

Model Number 3100A

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Other: at this time, no carefusion field service representative report has been received and the suspect device/component has not been returned for evaluation.Once the final evaluation report has been received then a follow up report will be submitted.

Event Description

The customer reported that this 3100a hfov (high frequency oscillating ventilator) unit failed to alarm when the minimum map (mean airway pressure) alarm was set at 11 and the map was reading 10.This occurred while on a patient.The customer stated that there was no injury or harm associated with this reported event, but alternate ventilation was electively provided by changing out this unit with a known good 3100a hfov.

Manufacturer Narrative

Results of investigation: the carefusion failure analysis lab received the suspect panel meter assembly and installed in into a known good 3100a high frequency oscillating ventilator for testing.The component and device calibrated normally and passed all tests to meet manufacturer specifications.The reported issue was unable to be duplicated and no malfunctions were detected with the suspect component.

• 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 ; 7149227830
• MDR Report Key: 5633065
• MDR Text Key: 44447506
• Report Number: 2021710-2016-03679
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 05/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2003
• 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): Other