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

Catalog Number 8604700

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported there was a leak in the fabius and the unit only functioned in manual ventilation mode.There was no injury reported.

Manufacturer Narrative

A dräger service engineer examined the device on-site and determined that the diaphragm of the so-called fresh gas decoupling valve was stuck open.After the diaphragm was re-seated the device passed all tests and could be returned to use.This finding explains the observation reported by the customer: if the fresh gas decoupling valve remains open during the inspiration phase breathing gas will flow through it towards the absorber instead of through the inspiratory valve to the patient.This leads to reduced automatic ventilation while manual ventilation is not impaired by this issue.It is confirmed for the particular case that the device posted the appropriate alarms to alert the user about the restrictions.The particular valve was manufactured in 2006.Typically, moisture in the breathing system or improper cleaning is a contributing factor for the sticking.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

Please refer to initial mfr.Report # 9611500-2019-00248.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNIT
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8901248
• MDR Text Key: 154956923
• Report Number: 9611500-2019-00248
• 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: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• 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: 8604700
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1