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

Model Number 10762472

Device Problem Mechanical Jam (2983)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

Siemens healthineers was informed of a potential product malfunction issue when using the luminos agile max system during an examination.It was stated that when the bottom edge of a table tilt button was pressed, the button stuck on the control handle (optigrip).The user was able to stop the movement before the table tilted too far.Movement stops when the user lets go of the optigrip.The user can also stop system movement by pressing an emergency stop button.No injury to the patient or user was communicated for this event.However, it is assumed that in worst case scenario, a minor to serious injury might be the outcome should the issue recur.

Manufacturer Narrative

H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: currently no general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: the investigation is ongoing.A root cause has not yet been determined.Siemens healthineers will submit a supplemental report if additional information is obtained upon completion of the investigation.

• Brand Name: LUMINOS AGILE MAX
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; 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: 18787215
• MDR Text Key: 337530575
• Report Number: 3004977335-2024-00025
• Device Sequence Number: 1
• Product Code: OWB
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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
• Date Manufacturer Received: 02/22/2024
• 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