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

Model Number 10502200

Device Problem Mechanical Problem (1384)

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

Event Date 12/17/2021

Event Type  malfunction  

Manufacturer Narrative

A self test of the emergency stop circuit is performed at system startup, however, a mechanical fault of the switch cannot be detected at startup.In this case, the user could have kept the button actuated by permanently keeping it pressed.It is noted in the operator manual to perform a daily check of the emergency stop buttons.Nevertheless, even though no injury occurred in the reported case, in worst case, a minor to serious injury might be the outcome if the emergency stop button does not work correctly in an emergency situation.The concerned emergency stop button was replaced on the unit and the functionality was confirmed.The system was brought back to specifications.Internal id # (b)(4).

Event Description

The emergency stop button at the patient table side on the luminos agile unit did not function properly following collision with a cart.It would actuate but not remain activated.No injury or patient involvement was communicated in this case.

Event Description

The emergency stop button at the patient table side on the luminos agile unit did not function properly following collision with a cart.It would actuate but not remain activated.No injury or patient involvement was communicated in this case.

Manufacturer Narrative

A self test of the emergency stop circuit is performed at system startup, however, a mechanical fault of the switch cannot be detected at startup.In this case, the user could have kept the button actuated by permanently keeping it pressed.It is noted in the operator manual to perform a daily check of the emergency stop buttons.Nevertheless, even though no injury occurred in the reported case, in worst case, a minor to serious injury might be the outcome if the emergency stop button does not work correctly in an emergency situation.The concerned emergency stop button was replaced on the unit and the functionality was confirmed.The system was brought back to specifications.Internal id # (b)(4).

• Brand Name: LUMINOS AGILE
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 13168268
• MDR Text Key: 285931739
• Report Number: 3004977335-2022-11112
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10502200
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other