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

Model Number 10502200

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2015

Event Type  malfunction  

Event Description

It was reported that a footboard of the luminos agile system became loose during the exam.The table was tilted to approximately 30 degrees with a patient standing on the footboard when it became dislodged and the patient slid off.No injuries were sustained as a result of this incident.

Manufacturer Narrative

The reported footboard was requested for further investigation.The reported issue is under investigation and a supplemental report will be submitted once additional information has been received.This report was submitted (b)(6) 2015.

Manufacturer Narrative

The investigation of the returned footrest showed breakage of the steering rail.This breakage has no safety related impact on the attachment of the footrest and its halt.It is assumed that the breakage in the rail was caused by an improperly attached footrest and following tilting.The detent and the bolts of the footrest are completely functional.Moreover all safety marks are visible.Therefore the investigated part did not show any defects regarding functionality and reliability of the footrest.It is assumed, that the footrest fell off because it was not properly attached by the user.Correct attachment of the footrest is described in the operator manual xpd1-320.620.01.02.02, chapter 8, pages 73 and 74.The footrest was replaced at the concerned customer site.This report was submitted april 1, 2016.

• Brand Name: LUMINOS AGILE
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; forchheim 91031 ; GM 91031
• Manufacturer Contact: anastasia mason ; 51 valley stream pkwy.; malvern, PA 19355-1406 ; 6102194834
• MDR Report Key: 4802416
• MDR Text Key: 17579753
• Report Number: 2240869-2015-12031
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 05/07/2015

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: 10502200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 05/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other