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

Catalog Number 8607000

Device Problems No Pressure (2994); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided within a follow-up report.

Event Description

It was reported that during the operation, the ventilation failed.The device posted an alarm and switched to manual ventilation.No injury reported.

Manufacturer Narrative

Further information as e.G.Log file and service report were requested for investigation at manufacturing site.Unfortunately no additional information was received so that no investigation could be performed and that finally no root cause could be determined explaining the reported symptom.In general in case of a ventilator failure automatic ventilation is not possible anymore.The device will generate an audible alarm and a visible alarm message "ventilator fail" will be displayed.The user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.The fabius is equipped with an integrated pressure- and volume-monitoring.

Event Description

Please refer to the initial-report.

• 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: 9381111
• MDR Text Key: 182190371
• Report Number: 9611500-2019-00399
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)190123(17)190623(93)8607000-72
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• 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?: No
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1