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

Model Number 10762471

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/15/2014

Event Type  malfunction  

Event Description

The customer was using the footrest during patient examination on the axiom luminos drf max system.The footrest fell off the table during the table tilt with patient on the table.There are no injuries attributed to this event.

Manufacturer Narrative

Siemens local service engineer was dispatched to the facility.The engineer determined that a table pad caused the footrest not to latch properly.The inspection of the board showed no damages or defects and confirmed that it operates properly.It was brought to the customer's attention that the table pads width and their location on table edge might cause some difficulties with latching the footrest.The customer is aware of this and advised the rest of the staff about proper footrest installation this report was submitted 01/13/2015.

• Brand Name: AXIOM LUMINOS DRF MAX
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY
• Manufacturer (Section D): SIEMENS AG; siemensstrasse 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS AG; siemensstrasse 1; forchheim 9130 1; GM 91301
• Manufacturer Contact: anastasia mason ; 51 valley stream pkwy.; msd-02; malvern, PA 19355-1406 ; 6102194834
• MDR Report Key: 4438223
• MDR Text Key: 18925219
• Report Number: 2240869-2015-09973
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/19/2014

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: 10762471
• Device Catalogue Number: NFA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 01/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other