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

Model Number 10094200

Device Problem Break (1069)

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

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

It is assumed that according to the provided images, the foot rest was not properly attached to the table - mounting of the footrest was too low.This led to the fact that the footrest extended to the table length and could not be detected by the system's collision algorithm.A supplemental report will be submitted if additional information becomes available.(b)(6).

Event Description

It was reported that a patient foot board hit the ground when the customer tilt the table in the morning.Siemens engineer was dispatched to the site to test the unit.The engineer witnessed system movements and they unit was running normal.There are no injuries attributed to this event.The reported event occurred in (b)(6).

Manufacturer Narrative

The investigation of the error logs showed that collision with the floor can be excluded as a cause of the incident.Furthermore the investigation of the returned parts (footrest and tabletop) showed that the lowest application points of the bilateral fixed profiles were pulled by an excessive force.This equal damage on both sides indicates that the footrest was used when the incident occurred.Therefore tests with a 6-fold load were performed, however the reported issue could not be reproduced.It is assumed that the damage occurred because of a collision with an obstacle.In the operator manual (xpd3-500.620.02.02.02, chapter [?]personal safety measures", page 24) it is stated that the operator has to ensure that no obstacles are in the area of collision.No systematic system failure could be detected and the issue could not be reproduced.This report was submitted october 18, 2016.

• Brand Name: AXIOM LUMINOS DRF
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS GMBH; siemensstrasse 1; erlangen, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern 19355 ; 6104486478
• MDR Report Key: 5729532
• MDR Text Key: 48354735
• Report Number: 2240869-2016-44489
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2016

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: 10094200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2016
• Initial Date FDA Received: 06/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other