MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM ICONOS R200; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 5902767

Device Problems Unintended Movement (3026); Insufficient Information (3190)

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

Event Date 12/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Siemens service engineer was called for troubleshooting and correction.Upon arrival the service engineer confirmed that the protective foil was still attached to the control console.It is possible that when activating the joystick for collimator or system movement, other joystick may also be activated.This includes the joystick for tilting.There are no clear indications that a system failure or malfunction has caused the event.A contribution of the protective foil wrapped around the control console cannot be excluded.The investigation of the log files did not show any failure or malfunction.The control console from the site was analyzed as well and did not any defects.A supplemental report will be submitted if additional information becomes available.(b)(6).

Event Description

On (b)(6) 2017 siemens was informed by its service organization of an unintended system movement of the axiom iconos r200 unit.Originally it was reported that the table movement occurred without operator touching the joysticks.An operator injury was reported in this case.Siemens conducted an investigation and clarified that during a clinical examination a physician and a medical technical assistant (mta) were standing on the one end of the table top while the patient was being placed on the system table.Another mta was standing next to the control console in the exam room.The control console was wrapped with a protective foil.According to a statement of the hospital staff, the system started to tilt head first.As the operator removed the protective foil from the control console, system movement stopped.The procedure continued, however, approximately one minute later the system tilted without given command again head first.That mta at the head end of the system table top grabbed the patient when the system started tilting to prevent the patient from falling off the table.While holding the patient, assistant's knee came under the table and got injured.Siemens is currently unaware of extent of the injury.(b)(6).

Manufacturer Narrative

The issue was investigated in detail.The analysis of the log files showed no entries for the time stamp of the event.The remote control desk of the examination room was returned and examined.All buttons and joysticks worked as intended.The remote control desk was installed in the test lab; it went under an endurance test for approximately 1.5 months.During this time no unintended movements occurred and no problems were identified.The spare part consumptions of the involved components remote control desk (07030708), cross switch potentiometer (07030765) and cross switch (07030757) were checked and all show values below the defined thresholds.No general problem is known.According to the information from the service technician the customer used their own protective foil over the remote control desk, which is not approved for the component.During the onsite investigation it was recognized that due to the protective foil that was stretched over the console it was possible for the switches to be activated unintentionally while operating another switch.Therefore, the user was advised not to use this foil over the remote control desk.No further problems are known from the customer site since the remote control desk was replaced and the foil was removed.The unit is working according to specifications.

• Brand Name: AXIOM ICONOS R200
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 7207463
• MDR Text Key: 97848730
• Report Number: 3004977335-2018-11090
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K992660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: 5902767
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2017
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention