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

Catalog Number 8604700

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

A dräger field service engineer has examined the device in follow-up of the event and could confirm the reported aspect of ventilator shut-down.It could be traced back to a malfunction of the light barrier in the motor position detection system.The motor drives the ventilator piston via a threaded spindle; the number of rotations is proportional to the hub of the piston and thus, to the volume the ventilator applies.If the motor position cannot be determined anymore this may result in potentially hazardous output.Consequently, the system is designed to force a shut-down of automatic ventilation when motor position detection fails.The device posts a corresponding alarm to alert the user and, manual ventilation with the built-in breathing bag remains possible.The replacement of the light barrier has put back the device into fully operable conditions.Dräger finally concludes that the system responded as intended upon the malfunction of a single component.The failure of an electronic component after 16 years of operation can be considered acceptable.

Event Description

It was reported that the device posted an alarm during patient use and stopped automatic ventilation.The patient was moved to another device, no consequences have reportedly occurred.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11176037
• MDR Text Key: 228953674
• Report Number: 9611500-2021-00024
• 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
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1