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

Model Number 10762472

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

It is assumed that "-" table tilt button was stuck.When the operator activated the dead man grip to move the system towards the "+" direction the table was tilted in the direction "indicated" by the stucked button.Investigation is on-going.A supplemental report will be submitted if additional information becomes available.Internal id (b)(4).

Event Description

Siemens became aware of an unintended system movement of the luminos agile max unit.The user reported that the table should have tilted upwards ("+" direction), when it moved in opposite direction -20 degrees.There are no injuries attributed to this event.

Manufacturer Narrative

Investigation showed that the described issue was caused by a specific hardware failure of the opti grip.It was found that a plastic part inside the opti grip (broken off the back of the fluoro button) jammed the button causing to it to get stuck in counterclockwise tilting setting when activated.At the time of the event the operator attempted to tilt the table back to 0°.Additionally, the "myelography button" was pressed, meaning that the tilting motion would not stop at 0°.Since the operator did not take the hand off the opti grip, the dead man switch remained active as well.This combination of events caused the table tilt movement to continue to its final position of - 20°.Had the user released the opti grip, the movement would have stopped immediately.The root cause for the breaking of the plastic part inside the opti grip could not be clearly determined.The one-sided signs of use indicate asymmetrical pressure applied to the button which may have contributed to the breakage over the years of use.However, no similar issues from the field are known.The replacement of the opti grip resolved the issue at the concerned user site.

• Brand Name: LUMINOS AGILE MAX
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr.1; forchheim, 91301 ; GM 91301
• MDR Report Key: 8712265
• MDR Text Key: 148429098
• Report Number: 3004977335-2019-85715
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

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: 10762472
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other