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

Catalog Number 8604700

Device Problems No Display/Image (1183); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided within our follow-up report.

Event Description

It was reported that the screen blanked out, and automatic ventilation was interrupted.There was no injury reported.

Manufacturer Narrative

On-site evaluation by a service technician revealed that a capacitor on a certain control pcb was short-circuited; evidence for that was found in terms of burn marks.The net effect is a breakdown of the internal 12v line which then causes a cut-off of other functional units from voltage supply.Automatic ventilation will be shut-down as reported, this is readily apparent to the user due to the screen black-out.In this state, manual ventilation is still possible with total fresh gas parameter to be observed from the additional mechanical flowmeter.The safety feature preventing overdose of nitrous oxide is also mechanical and thus, independent from supply voltages.The 14 year old device incorporates a design that has been improved in 2007 already, especially in regard to the 12v supply stage.The replacement of the particular pcb has put back the device into fully operable condition.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

Please refer to initial mfr.Report #9611500-2019-00050.

• 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: 8338668
• MDR Text Key: 137443374
• Report Number: 9611500-2019-00050
• 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: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• 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: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.