MAUDE Adverse Event Report: SIEMENS AG AXIOM LUMINOS TF; SYSTEM, X-RAY, FLUOROSCOIC, IMAGE-I

Model Number 10093902

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Pain (1994)

Event Date 01/28/2015

Event Type  malfunction  

Event Description

Siemens was notified that a bariatric pt was standing on the foot rest of the axiom luminos tf system during a fluoroscopic study.After phase 1 was completed with the pt standing at 68 degree angle on the foot rest, the table was returned to 45 degree angle position for the pt to rest.Once the physician assistant and the technologist present in the exam room for the study returned the table to approx 68 degree position to continue with the study, the foot rest broke off first from the right side of the table and then from the left side.The pt slid to floor and hit his neck/head on the base of the table.The pt was assessed at the facility.The pt complained of diffuse pain but on injury was sustained; no medical intervention was required.

Manufacturer Narrative

Siemens service engineer visited the site.The engineer checked the foot support and table top; he attached the foot rest and it locked in place properly and held in securely.The engineer noticed some usual wear and tear on the foot support and recommended to the customer for the part to be replaced.The operator manual requests that daily tests are carried out on the system, including attaching and detaching of the footrest to ensure the foot support is securely functioning.This report was submitted march 27,2015.

• Brand Name: AXIOM LUMINOS TF
• Type of Device: SYSTEM, X-RAY, FLUOROSCOIC, IMAGE-I
• Manufacturer (Section D): SIEMENS AG; siemensstrasse 1; forchheim 9130 1; GM 91301
• Manufacturer Contact: anastasia mason ; 51 valley stream pkwy.; ms d-02; malvern, PA 19355-1406 ; 6102194834
• MDR Report Key: 4653057
• MDR Text Key: 18035020
• Report Number: 2240869-2015-01226
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 03/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other