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

Model Number 3100A

Device Problem Failure to Cycle (1142)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2014

Event Type  malfunction  

Event Description

The customer reported that the device stopped running while in patient use, no patient compromise.The vent alarmed to alert them that the driver stopped so they were able to quickly switch the patient to another 3100a vent without incident.

Manufacturer Narrative

(b)(4).The customer replaced the driver display indicator pcb to resolve the issue.

Manufacturer Narrative

Additional manufacturer narrative.This supplemental report was identified as a late submission during a two year retrospective review of complaints and mdr¿s following receipt of an untitled letter issued by the fda.The original date of awareness was reported as (b)(6) 2014.The information for this follow-up report was noted on 9/30/2015.Corrected data: life threatening and required intervention to prevent permanent impairment/damage were added because the ventilator required change out.Malfunction.No patient injury.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY/LSZ
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• 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: 4332008
• MDR Text Key: 5254255
• Report Number: 2021710-2014-00083
• 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 Facility,health professional,use
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• 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: 768901-103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention