MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION CC; VENTILATORS, INTENSIVE CARE

Model Number V500

Device Problem Fire (1245)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation was started but is not yet concluded.The investigation result will be reported in a follow up-report.

Event Description

It was reported that at approximately 07:25 on (b)(6) 2016, 10 - 15 minutes after a nebulizer treatment with duoneb was started and fio2 was decreased from 100% to 50%, a fire was observed at the area of the flow sensor /expiratory port.The patient was removed from the ventilator.No injury was reported.

Manufacturer Narrative

The sensor and part of the device were investigated at the manufacturer.The root cause of the reported event was that combustible material solid, liquid or vapor, inside the flow sensor was deposited at or near the measurement wires of the flow sensor.These wires will be pyrolytically cleaned after nebulization.Clean wires are necessary for accurate flow measurement.Thus, the wires are heated up to approximately 900 °c.Due to the little mass of pollution deposited on the wires, the necessary energy to burn this material is very small.Thus this action happens very fast and the surface of wire supports and the flow sensor itself are not heated up under usual conditions.In this case the matrial was ignited by the hot wire (approx.900°c) during calibration.The origin of the amount of material necessary to ignite is unknown.The spirolog flow sensor measuring system was damaged.The ventilator will detect the faulty flow sensor.The user would be alerted to this condition by an audible alarm and a visual message would be posted in the display.Generally ventilation is not affected, but the necessary actions to extinguish the fire: interruption of gas supply and exchange of ventilation, had caused an interruption of ventilation.As the flow sensor is located at the expiratory port, the gas flow is not in patient direction.Also in this case the patient did not inhale flue gas.This is the first reported event of this kind in relationship with the infinity workstation v500.The instructions for use of the ventilator and the flow sensor contain several warnings and cautions concerning risk of fire in context of nebulization and cleaning.After replacing all components used for investigation the device was repaired and given back into service.

Event Description

Please see initial-report.

• Brand Name: INFINITY ACS WORKSTATION CC
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 5716793
• MDR Text Key: 47126982
• Report Number: 9611500-2016-00162
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Model Number: V500
• Device Catalogue Number: 8416000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1