MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH - AT AXIOM ARTIS DTA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 7008605

Device Problems Unintended Collision (1429); Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that a malfunction occurred while operating the axiom artis dta.The user reports that a cable holder dropped down from the ceiling.At this time, we are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

The investigation showed that the reported issued was caused by a mechanical impact.A collision between the corrugated hose and the support arm of the upper body radiation protection, which was controlled by the user, occurred.This caused too much tension on the holder of the corrugated hose and caused it to detach from its mounting.Note: without external interference of the system by another object, the holder would have followed the movement of the system into parking position and the reported incident would not have occurred.The concerned unit has been in service for 14 years of operation and no error accumulation has been identified.Details on how to move the system are provided within the instruction for use (ifu); it is advised to be aware of other objects and avoid possible collisions.The incident was not a result of system failure, but a user error.The affected holder has been reinstalled by siemens local service organization.The reported issue has not reoccurred.

• Brand Name: AXIOM ARTIS DTA
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10179128
• MDR Text Key: 195933639
• Report Number: 3004977335-2020-32793
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K052202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7008605
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1