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

Catalog Number 8604700

Device Problem Device Slipped (1584)

Patient Problems Bone Fracture(s) (1870); No Patient Involvement (2645)

Event Date 09/07/2018

Event Type  Injury  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

Event Description

It was reported that one of the three drawers of the anesthesia device was pulled out of the guides when opened by an operator.This caused a fracture of the scaphoid of the left hand.Surgery and subsequent immobilization of the arm were necessary.The patient was not involved in the accident and did not injured.

Event Description

Please refer to the initial report.

Manufacturer Narrative

The investigation was carried out based on the available information and the provided photos as well as the analysis of the complaint material.The affected drawer and the two telescopic slides (guides=tracks) have been inspected and tested in a fabius gs premium test device in the manufacturer¿s lab.Additional information about the circumstances of this event had been requested.It was reported that the user pulled out the upper drawer with both hands and the drawer fell down.By trying to prevent that the filled drawer falls to the ground, the user received a knock causing the reported injury.The drawer was equipped with intubation accessories of approximately 2 kilograms weight which is within the fabius specification.The investigation of the replaced drawer by the manufacturer¿s engineering team revealed no abnormalities either.It was found that, if the drawer will be pulled out above the ordinary pulling force or too lateral, it is possible that the metallic latches dislodges in case the user pulls the drawers too strong against the end position.This is obvious as it is hearable, tactile and visible for the user.In this case, it is easy to snap the drawer again by closing the drawer.During use, in case of an issue with the drawers, the performance or functionality of the device will not be affected.Since 2014, in the framework of a continuous product improvement, the tracks are equipped with threaded holes instead of brackets and each drawer is fixed with four screws to the slides additionally.The affected drawer has already been replaced by a drawer of new style.Within the last three years, no similar incidents have been reported.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 7921780
• MDR Text Key: 122154156
• Report Number: 9611500-2018-00319
• 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: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1