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

Catalog Number 8604700

Device Problems Gas Output Problem (1266); Loss of Threshold (1633); Failure to Deliver (2338); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that the device displayed a ventilator position error during a case.There was no injury reported.

Manufacturer Narrative

The device was evaluated on-site by a dräger fse who could confirm the reported motor position error - corresponding entries were found in the logs.These error entries will be generated when it is not possible to zero the ventilator piston position encoder.Additionally, codes were recorded that indicate that the motor current consumption was significantly increased.The engineer has replaced the ventilator motor including the position detection system.The device was tested, performed according to specifications and could be returned to use.The replaced material was not made available to the manufacturer for investigation.Hence, a detailed root cause is not possible.Dräger finally concludes that the device responded as designed upon a detected deviation.If it is not possible to adjust the zero point of the position encoder this may lead to erroneous motor control signals and result in serious damages to the system.To prevent from that, the device software shuts down automatic ventilation and triggers a corresponding alarm to alert the user.Manual ventilation remains possible.

Event Description

Please refer to initial mfr.Report.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9139493
• MDR Text Key: 183769298
• Report Number: 9611500-2019-00302
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• 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?: Yes
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1