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

Model Number 10762472

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer narrative: initial corrective actions/preventive actions implemented by the manufacturer: the user facility was advised to not use the system any further in the current condition.No general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: operator inattentiveness is seen as the cause for the issue.The investigation is ongoing.A supplemental report will be submitted to the fda if additional information becomes available upon completion of the investigation.

Event Description

The emergency stop button broke off the table when a patient bed collided with the table when it was brought into the room to get the patient off the table.Provided pictures show that not only the cap of the emergency stop button was missing, but that the whole switch was torn off the table.There were no injuries associated with the event.Two risks are seen in this case: if the operator continues to use the system with the defective emergency stop switch, a collision might not be prevented in an emergency situation, if the user does not press an alternative emergency stop button.This might result in worst case in a serious injury.In case of failure of the emergency stop at the tabletop, the user can stop any movement immediately with further emergency stop buttons located on the bucky wall stand (if available) and on the control room module / remote control console.The second risk seen in this specific case is that body parts of a person might have been crushed between the tabletop and the patient bed, since the provided pictures suggest that the table was driven downwards onto the patient bed: the cover of the emergency stop switch was torn away from the bumper and bent upwards.This also might result in worst case in a serious injury.The operator is responsible for ensuring that no objects are in the collision range when moving the system.There is a corresponding note in the operator manual.

Manufacturer Narrative

H3, h6: the described issue was investigated in detail.It was initially stated that the emergency stop button broke off when the operator lowered the system onto a stretcher during a patient transfer.The type of stretcher / patient bed could not be clarified.The customer was advised not to use the system until it was repaired but decided to continue using it at their own risk.To protect the button from collisions, a rubber ring bumper is placed around the housing by design.The button does not protrude and can only be damaged if it is directly hit by, for example, the corner of a patient bed.It cannot be completely protected from collision because it must be easily accessible.The rubber housing is glued to the aluminum bumper.If enough force is applied to the rubber housing, it may be possible to loosen the glue and the rubber panel will lift off the aluminum bumper.Substantial force can be applied if the stretcher is pushed against the ring from the side or if the table is lowered onto the stretcher at the position of the rubber ring.This would also damage the emergency stop button.In the worst case (as in this case), the whole button breaks off and cannot be actuated anymore.In general, it is recommended to check the functionality of the emergency stop buttons after each start up as described in the operator manual.With this, defective emergency stop buttons will be detected by the user.According to the service organization, the service engineer replaced the defective button on the same day the complaint was received.The spare part consumption of the concerned part (material number 4699351) was checked.No general problem was found.Nevertheless, the issue of damaged emergency stop buttons will be further tracked by the product steering group which will decide about further measures.In case of an emergency, additional emergency stop buttons are located on the bucky wall stand and on the control room module in the examination room.These can be used in case of failure of the tabletop emergency stop.Another way to stop movement and radiation is to turn off the system at the control room module or a wall breaker (if installed).The complaint is closed with this statement and without further measures.

• Brand Name: LUMINOS AGILE MAX
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17405113
• MDR Text Key: 320024548
• Report Number: 3004977335-2023-00068
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869009162
• UDI-Public: 04056869009162
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1