MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS GS; ANESTHESIA UNITS

Catalog Number 8604700

Device Problems Device Emits Odor (1425); Device Displays Incorrect Message (2591); Device Difficult to Maintain (3134)

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

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

The fabius log file was analyzed for the reported date of event (b)(6) 2016.Two entries show that the system and patient circuit tests failed which are part of the daily device check performed before use as described in the ifu.Obviously these results were ignored by the user and the device was put into operation.The reported symptoms of the smell of sevo in the room and the difficulty maintaining the set pressure can be attributed to leakages into room air which were already detected during the pre-use check.The log analysis also revealed that on the date of the reported event a ventilator failure occurred which was reason for the belated reporting.During operation when the ventilator piston is moving down a vacuum is present leading to fresh gas flowing into the cylinder.When the pressure inside the ventilator is about -5mbar a ¿fresh gas low¿ alarm is generated by the fabius.In case of a continued fresh gas deficit reaching a cylinder pressure of -8mbar an auxiliary valve located on the top of the ventilator opens to dose ambient air into the cylinder.If this valve is sticking the cylinder pressure can drop to a level of -15mbar.In this state the message ¿vent pressure very negative¿ is entered to the logs as happened in this case.Further the piston pressure controller stops the ventilator as a precaution and the alarm ¿ventilator fail¿ is generated.The ventilation can be continued manually as performed by the user.A sticking valve membrane of the auxiliary valve can be caused if the cleaning and disinfection recommendations are not followed as described in the ifu.To determine the root cause in more detail additional information was requested but was not provided.

Event Description

It was reported that during a case, while in automatic mode, the machine alarmed for ¿fresh gas low.¿ reportedly the smell of sevo was present in the room and the user had difficulty maintaining the set pressure.The case was reportedly completed using manual mode ventilation.No patient injury reported.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• 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: 6248799
• MDR Text Key: 65205708
• Report Number: 9611500-2017-00012
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• 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 Catalogue Number: 8604700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2004
• 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