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

Model Number 3100A

Device Problems Thermal Decomposition of Device (1071); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).This complaint file was identified as meeting the criteria of mdr submission to the fda during a retrospective review of complaints.(b)(4).Results of investigation: a carefusion field service representative (fsr) evaluated the device on site.The fsr found a capacitor on the alarm board had smoked.The fsr replaced the alarm board.The capacitor had been eliminated from the design.The fsr did a complete pneumatic adjustment of the ventilator.The ventilator meets patient circuit calibration and performance check specifications.The carefusion failure analysis laboratory received the suspect component, a 3100a alarm board assembly, and evaluated the device.An evaluation of the component duplicated the reported issue.The capacitor that was found burnt is not part of the build of materials, it is an extra part.

Event Description

The customer reported that the user smelled a burning smell and saw smoke coming from the electronics area of the ventilator while the unit was in use on a patient.There was no patient compromise.The unit kept running without incident.The patient was switched to another unit.The biomedical engineer investigated the unit and found that a capacitor on the alarm board was burnt.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATORY 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: 6254328
• MDR Text Key: 64898168
• Report Number: 2021710-2017-05245
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/16/2017

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: 11/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2014
• Initial Date FDA Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2000
• 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