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

Catalog Number 8607000

Device Problems Device Alarm System (1012); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

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 device posted a "apnea pressure, vent fail" alarm.The procedure was continued by ventilating the patient manually.No injury reported.

Manufacturer Narrative

The log file and the description of event have been analyzed.The log contains an error code that indicates a problem with the vacuum pressure.This vacuum pressure is needed to keep the piston diaphragm in place to avoid wrinkling during piston movement.If the vacuum pressure drops below a certain limit the device is designed to shut down automatic ventilation to prevent from serious damages to the ventilator unit.This is accompanied by a corresponding "vent fail" alarm.The other type of alarm that was reportedly observed, "apnea pressure", is a secondary alarm caused by the ventilator failure since the airway pressure monitoring does not detect gas volume shifts anymore until the user starts the manual ventilation.Potential root causes for the vacuum pressure problem are manifold in general.Certain technical error conditions would produce further log entries which are not present in the relevant period.For example - if the issue would be related to a malfunction of the vacuum pump, a corresponding entry will be recorded.Due to the absence of such further error entries it is seen likely that a leakage in the control tubing for the apl bypass valve has caused the problem.The related tube is routed at the outside of the workstation and may have been damaged during operation somehow or simply pulled-off from dedicated connector.The device is 9.5 years old with unknown service state.Dräger recommended to the user facility to have the device checked by a local service technician against full scope of specifications.It is finally concluded that the device reacted as designed upon a significant disturbance.The user managed the situation by using the built-in breathing bag after the shut-down of automatic ventilation.

Event Description

It was reported that during the operation, the device posted a "apnea pressure, vent fail" alarm.The procedure was continued by ventilating the patient manually.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: 8953507
• MDR Text Key: 186752429
• Report Number: 9611500-2019-00264
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2019
• 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: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1