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

Model Number 10093902

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2021

Event Type  Injury  

Manufacturer Narrative

The concerned footboard as well as the footboard screw, latching mechanism, and rail catches were inspected; the system was moved to 90 degrees and the footboard tested again with 200 pounds of weight with no issues.The user was advised how to check on proper attachment of the footrest.Internal id # (b)(4).

Event Description

Siemens became aware of an incident on the axiom luminos tf device.When the user attached the footboard to the system, it detached from the rails once the patient stepped on it.The patient reported back pain as a result of the incident, however, no injuries were attributed to this event.

• Brand Name: AXIOM LUMINOS TF
• 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: 13095518
• MDR Text Key: 285189240
• Report Number: 3004977335-2021-10508
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051602
• 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: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10093902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other