MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. AXIOM LUMINOS TF; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 10093902

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problems Laceration(s) (1946); Seizures (2063)

Event Date 08/17/2015

Event Type  malfunction  

Event Description

Fluoroscopy system during a procedure got stuck in the trendelenburg position.The patient had a seizure, a lacerated tongue, and required hospital admission following the outpatient procedure.

• Brand Name: AXIOM LUMINOS TF
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 40 liberty blvd.; mailcode 65-1a; malvern PA 19355
• MDR Report Key: 6102123
• MDR Text Key: 59943985
• Report Number: 6102123
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 10093902
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2016
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Outcome(s): Other