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

Model Number 3100A

Device Problems Device Emits Odor (1425); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should any additional information be received by the customer then an additional report will be submitted.(b)(4).A carefusion field service representative (fsr) conducted an evaluation of the suspect device on the reporter's facility site.The fsr ran the unit on various levels and settings and was unable to duplicate the reported issue of a burning smell or the driver shut-down.Scheduled preventative maintenance was performed and the unit passed all calibrations and performance checks, meeting the manufacturer specifications.At this time, carefusion has not conducted an investigation of the returned component.Should an investigation be done, a supplemental report will be submitted.

Event Description

The customer reported that this 3100a high frequency oscillating ventilator emitted a burning rubber smell and then shut down.The customer stated that this occurred during a pre-use check and that there was no patient involvement.

Manufacturer Narrative

Results of investigation: the carefusion failure analysis laboratory received the suspect component, a 3100a power driver module assembly, and evaluated the device.An evaluation of the component did not duplicate the reported issue.The power module was placed into a known, good test fixture and ran without any overheating issues.The power driver module calibrations were performed and no issues were found.

• 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: 5671590
• MDR Text Key: 45887406
• Report Number: 2021710-2016-03769
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• 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