MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY AXIOM ARTIS DBA; INTERVENTIONAL, FLUOROSCOPIC, XRAY SYSTEM

Model Number 7555357

Device Problem Unintended Arm Motion (1033)

Patient Problem No Information (3190)

Event Date 05/06/2016

Event Type  Injury  

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 while performing an examination on the axiom artis dba system, a patient was injured.While transferring a patient from a stretcher to the exam table, the technologist was on the opposite side of the table and pushed down on the dmg function while pulling the patient onto the table.This activated the lao/rao motion of the c-arm and the c-arm traveled toward the patient, pinning him to the stretcher.We are unaware of the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.No system failure or malfunction could be identified.An individual "user error" has been determined as the root cause.Based on log file assessment, the investigation did not show any indication of unintended movement.The collision protection of the system works correctly.The area between the fd and table is part of the collision protected area.The artis system provides collision protection by displaying a "safety guard active" message due to collision.The system is able to be removed from the collision area by reverse movements.Additionally, the operator manual gives adequate information how to move the system carefully and how to prevent from collisions.

• Brand Name: AXIOM ARTIS DBA
• Type of Device: INTERVENTIONAL, FLUOROSCOPIC, XRAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 5717028
• MDR Text Key: 47129343
• Report Number: 2240869-2016-41988
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Model Number: 7555357
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2006
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR
• Patient Weight: 77