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

Model Number 5902775

Device Problems Unintended System Motion (1430); Use of Device Problem (1670); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

Table tilt controller and table side controller have been already exchanged at this site.The unit works as specified.Investigation is on-going.A supplemental report will be submitted if additional information becomes available.

Event Description

Siemens became aware of unintended table movements on the axiom iconos r200 unit.The x-ray table tilted from 90 degree to 0 degree position without given command.Siemens is not aware of any patient involvement in this case.

Manufacturer Narrative

The reported issue was investigated based on the information received and the provided error logs.The replaced parts were not available for investigation.The analysis of the log files showed no indication of malfunction.The issue could have been caused by one of the two hardware issues - stuck tilt button on the table side control or a de-calibrated /defective joystick in the remote control desk.The two components (table side control, material number 7030773 and cross switch with poti, material number 7030765) have been already replaced at the customer site.The replaced parts were requested for further analysis; however, they had been disposed locally.A detailed investigation was therefore not possible.However, both affected parts show low values in spare part consumption.Therefore, no systematic issue is identified.The problem did not recur since the joystick and table side control desk were replaced.

• Brand Name: AXIOM ICONOS R200
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr.1; forchheim, 91301 ; GM 91301
• MDR Report Key: 8504197
• MDR Text Key: 145915584
• Report Number: 3004977335-2019-70845
• 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
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

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: Health Professional
• Device Model Number: 5902775
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other