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

Catalog Number 8604700

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); No Pressure (2994); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

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 there was a ventilator fail during use.There was no injury reported.

Manufacturer Narrative

The investigation of the log file revealed that there was an issue with the vacuum pressure at the reported time of event.This vacuum pressure is needed to keep the diaphragm of the ventilator in place to avoid wrinkling during piston movement.If significant deviations are detected the software forces a shutdown of automatic ventilation to prevent from serious mechanical damages to the ventilator unit.This shutdown is accompanied by a corresponding alarm; manual ventilation and the monitoring functionalities remain available.The imaginable root causes for a vacuum pressure error are manifold: a puncture of the piston diaphragm, a leak in the assembly of the dedicated pneumatic circuit, leaks inside the pump, pump calibration error etc.The particular device is 15 years old.The dispatched service technician replaced the vacuum pump, the peep valve and the processor board; the device passed all consecutive tests and was returned to use w/o further problems reported since then.It is not exactly known which measure was the one that rectified the problem since the replaced parts exhibited no malfunctions during a test run over three days in the manufacturer's lab.Hence, a clear root cause cannot be assigned by dräger.It can however be concluded that the workstation responded as designed upon a deviation in one of the subsystems - a safety shut-down of automatic ventilation was forced, the user was alerted by means of a corresponding alarm; all alarms, potential root causes and dedicated remedies are explained in detail in the ifu.There was no injury reported.

Event Description

Please refer to initial mfr.Report #9611500-2019-00445.

• 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: 9480496
• MDR Text Key: 186762633
• Report Number: 9611500-2019-00445
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 02/25/2020
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1