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

Catalog Number 8607000

Device Problems Failure to Deliver (2338); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2020

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 the ventilator shut down during use.There was no injury reported.There was no injury reported.

Manufacturer Narrative

The electronic device logfile was needed and requested for root cause analysis.Unfortunately, as further reported, the biomed has neither sent the logs nor provided any further additional information.It was only reported that biomed checked the device in follow-up to the event and logfile entries were found pointing to an ac power fail.It was also reported that the fabius ran without any errors when checked by the biomed.Therefore, it is possible that a use error led to the reported symptom instead of a technical device malfunction.Nevertheless, due to lack of information, the exact root cause could not be determined.A check if the battery is fully charged is part of the pre-use check as described in the instruction for use and must be carried out before each patient use.With fully charged batteries, operation can be maintained for at least 45 minutes.In case of an ac power supply failure, the fabius device switches to battery supply automatically so that the case can be continued using battery power.This is optically and acoustically alarmed by the device and is additionally indicated to the user by the switched-off mains power led located on the user interface.If the battery is running low, additional alarms are generated at a battery charge state of 20% and 10%.A discharged battery will cause a deactivation of the automatic ventilation and is accompanied by an optical and acoustical "vent failure" alarm.In case of a total loss of the electrical power, the backup beeper will generate an acoustical alarm tone.The procedure can be continued using manual ventilation but without integrated monitoring.

Event Description

It was reported that the ventilator shut down during use.There was no injury reported.There was no injury 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: 10859103
• MDR Text Key: 223205906
• Report Number: 9611500-2020-00415
• 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: 11/02/2020,01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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?: No
• Date Report to Manufacturer: 11/02/2020
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1