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

Model Number 10094200

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of this event.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(6).

Event Description

Siemens became aware of an unintended table movement of the axiom luminos drf unit.The patient table moved automatically and without given command upwards and in tilting directions.There are no injuries attributed to this incident.The reported incident occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.The analysis of the log files confirmed a continuous tilting signal (without dmg activation).Until this continuous tilting signal is detected and the joystick is blocked by system, it is possible that the tilt axis may be moved due to intended operation of another axis and the associated activation of the dmg.The visual inspection of the joystick did not show any abnormalities.The mechanics worked properly without "clamping points".The part "jumper plug" to avoid open inputs was available as well.Therefore, the joystick was installed at a test system for deeper analysis.During test system startup no error messages were displayed.The described phenomenon (signal unintentional, active without operating action) could not be reproduced.If the described situation had been present, the continuous signal would have generated an error message during system startup.During the function tests the component did not show any deviations.Furthermore, the system has its own test tool, however, no deviations were detected.The tilt axis was working properly as well.After completion of the investigations, the joystick remained in the test system for further observation since this unit is used regularly.In the past four weeks and more, no malfunction of the tilt axis was detected.The described unintended movement could not be reproduced during the investigation phase.Based on the investigation results, no malfunction could not be detected on the returned joystick.Therefore, it is not assumed that a hardware fault of the joystick could have caused the unintended handling signal.According to information received there were no further issues after the joystick was replaced at the user site.

• Brand Name: AXIOM LUMINOS DRF
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10384446
• MDR Text Key: 209427626
• Report Number: 3004977335-2020-40350
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K062623
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094200
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other