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

Device Problem Break (1069)

Patient Problems Fall (1848); Pain (1994)

Event Date 01/28/2015

Event Type  malfunction  

Event Description

Bariatric patient to fluoro for ugi series.Phase 1 complete with patient at a 68 degree angle and standing on foot plate.Patient returned to 45 degree and to rest in between phases.Pa and technologist in the room for phase 2.Table returned to approximately 68 degrees when right side of foot plate broke from table, then left.Patient had uncontrolled slide to floor, and hit his neck/head on the base of the table.Patient assessed and no injury/trauma noted.The patient had complaints of diffuse pain.The fall will not impact the patient's los and discharge will be on schedule.

• Brand Name: AXIOM LUMINOS
• Type of Device: SYSTEM, X-RAY
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 810 innovation drive; knoxville, TN 37932
• MDR Report Key: 4522838
• MDR Text Key: 5354816
• Report Number: 4522838
• Device Sequence Number: 1
• Product Code: JAA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/29/2015

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: Health Professional
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2015
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 161