MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. AXIOM ARISTOS FX PLUS; STATIONARY X-RAY SYSTEM

Model Number 10093864

Device Problem Detachment Of Device Component (1104)

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

Event Date 07/24/2014

Event Type  malfunction  

Event Description

During an exam, a detector on the axiom aristos fx plus system was positioned under the patient table approximately 70 cm above the floor.During the examination, the telescope abruptly fell down to the floor.No system movements were initiated that could have triggered fall.There are no injuries attributed to this event.This event occurred in (b)(6).

Manufacturer Narrative

Additional information and the telescope were requested by our factory experts for further investigation.The reported issue is under investigation and a supplemental report will be submitted once additional information has been received.(b)(6).

• Brand Name: AXIOM ARISTOS FX PLUS
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream pkwy.; ms d-02; malvern PA 19355 140
• Manufacturer Contact: anastasia mason ; 51 valley stream pkwy.; ms d-02; malvern, PA 19355-1406 ; 6102194834
• MDR Report Key: 4077197
• MDR Text Key: 4898769
• Report Number: 2240869-2014-06230
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K013826
• 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: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10093864
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2014
• 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