MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. AXIOM MULTIX MT; RADIOLOGIC TABLE

Model Number 8395415

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 10/14/2014

Event Type  malfunction  

Event Description

A customer reported the 3d tube was stiff to move on the multix mt system and requested service.A siemens engineer was dispatched to the facility.Upon inspection the engineer noticed that het transverse roller was hanging over the edge of the rail.The securing pins for the transverse bridge assembly came out and were not locking the transverse rail to the carriage unstable.Although there have been no report of any injuries in this event, the whole 3d assembly could potentially crash down during an examination.The reported event occurred in the (b)(6).

Manufacturer Narrative

The concerned system was repaired by the engineer and returned to service.A customer site visit was planned by the development expert.The reported issue is under investigation and a supplemental report will be submitted once add'l info has been received.Customer's address: (b)(6).This report was filed (b)(6) 2014.

• Brand Name: AXIOM MULTIX MT
• Type of Device: RADIOLOGIC TABLE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream pkwy.; ms d-02; malvern PA 19355 140
• Manufacturer (Section G): SIEMENS AG; siemensstrasse 1; forchheim 9130 1; GM 91301
• Manufacturer Contact: anastasia mason ; 51 valley stream pkwy.; ms d-02; malvern, PA 19355-1406 ; 6102194834
• MDR Report Key: 4269192
• MDR Text Key: 5029257
• Report Number: 2240869-2014-08382
• Device Sequence Number: 1
• Product Code: IZZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K971452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8395415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other