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

Catalog Number 8607000

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

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 a ventilator failure was displayed during use and only manual bag ventilation was possible.There was no injury reported.

Event Description

Please refer to initial mfr.Report #9611500-2018-00392.

Manufacturer Narrative

A dräger service technician was dispatched who could determine that the vacuum pump was faulty.The vacuum pressure is required to keep the ventilator piston diaphragm in place to avoid wrinkling.When this vacuum pressure drops below a certain threshold during an automatic ventilation mode the device shuts down automatic ventilation to prevent from serious damages to the system.The shut down is accompanied by a corresponding alarm to alert the user about this condition.When in this state, manual ventilation remains possible; monitoring is still functional as well.Reportedly the problem was rectified; the device is back in use.The ffr of the particular pump with the specific failure mode is extraordinarily low.Dräger finally concludes that the device responded as specified upon a deviation detected by the self-monitoring function of the software.The patient was manually ventilated, no health consequences have been reported.

• Brand Name: FABIUS GS PREMIUM
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8154286
• MDR Text Key: 130329025
• Report Number: 9611500-2018-00392
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• 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: 8607000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1