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

Catalog Number 8607000

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Deliver (2338); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results will be provided in a separate follow up-report.

Event Description

It was reported that the ventilator failed during use.There was no injury reported.

Manufacturer Narrative

The log file evaluation revealed that the device had shut down automatic ventilation during the course of event due to a problem with the auxiliary vacuum pressure.The device needs a vacuum pressure inside the piston to keep the piston diaphragm in place i.E.To avoid wrinkling of the diaphragm during piston movement.If this vacuum pressure drops below a certain threshold necessary for safe operation the device is designed to shut down automatic ventilation to prevent from serious damages to the ventilator unit.The shut-down is accompanied by a corresponding alarm; patient support can be continued in manual ventilation with the built-in breathing bag.On-site examination of the device performed by a dräger technician revealed that a leakage was present at the ventilator lid.The ventilator lid was replaced and some other issues with the device were rectified as well.The device passed all consecutive tests and was returned to use.Dräger finally concludes that the workstation responded as designed upon a deviation; automatic ventilation was shut down to avoid severe damages and the user was alerted to the shut-down by means of a dedicated alarm.No patient consequences have occurred.

Event Description

Please refer to initial mfr.Report #9611500-2020-00170.

• Brand Name: FABIUS GSP
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10086014
• MDR Text Key: 192014028
• Report Number: 9611500-2020-00170
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• 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: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1