MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY AXIOM ARTIS ZEEGO; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 10280959

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2017

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 zeego system.During a clinical procedure with a sedated patient, the system froze and the customer was not able to move the c-arm.A system restart was performed and the system was again functional.The procedure was completed and we are unaware of any impact to the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Investigation results determined the system worked as specified and the error was caused by the operator by using the override mode until safety end stop.The investigation showed that the system stopped moving because the collision guard was activated.The customer continued movements using the override mode.This is a special safety mode which can be used after a collision occurs.The operator must press two buttons simultaneously and then he can move the c-arm by using the joystick.This is to be used for rescue reasons only and not for normal system operation as described in the operator instruction.This special mode is indicated at the system and the message "collision control deactivated" appears.The operator is aware of this rescue function and is responsible for control of any movement.In this case the customer used the override mode until he reached the final limit of the robot safety zone, which prevents collision with the floor and damage of the system.This safety function also prevents persons from getting squeezed between the floor and the c-arm.For this reason, the system is designed to stop immediately when reaching this point and no further motorized movement is possible.The manual safety rescue function remains operational to keep the patient safe.The system was brought back to operation by the local service organization and the issue did not reoccur.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: AXIOM ARTIS ZEEGO
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6420688
• MDR Text Key: 70698090
• Report Number: 2240869-2017-72697
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141574
• 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: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10280959
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1