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

Catalog Number 8607000

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Infusion or Flow Problem (2964); No Flow (2991); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained about intermittent ventilator failure alarms during use.There was no injury reported.

Manufacturer Narrative

The involved device is not under dräger service contract.The hospital's biomed has submitted photos from the error logs of the device.It can be seen that the supervisor function of the software detected repeated instances of vacuum pressure errors.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.This expertise was transmitted to the biomed who reportedly performed some intervention at the anesthesia workstation and get it back working.It is not exactly known which measure was the one that rectified the problem.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.There was no injury reported.Remark: in total, 3 occurrences of the sporadic ventilator failure were reported by the user facility.The mdrs 9611500-2020-00012, 9611500-2020-00013 and 9611500-2020-00014 reflect these.

Event Description

Please refer to initial mfr.Report #9611500-2020-00013.

• 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: 9601083
• MDR Text Key: 175421102
• Report Number: 9611500-2020-00013
• 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: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other