MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM ARISTOS FX PLUS; STATIONARY X-RAY SYSTEM

Model Number 10093864

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the incident.The concerned unit was reinstalled at a different location in (b)(6) 2020.It is unclear whether this site change contributed to the described event.The unit was repaired by siemens local service organization.A supplemental report will be submitted if additional information becomes available.Internal id #: (b)(4).

Event Description

Siemens was informed that the tube column side cable holder on the axiom aristos fx plus system dropped from rail fix point.There is no patient involvement in the reported incident.No injuries are attributed to this event.The reported event occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.The analysis of the provided pictures showed that the ceiling screw connection of one cable holder had become loose causing one loop of the grooved hose to drop down about 50 cm.The cables in the grooved hose prevented it from falling completely down.These screw connections are secured with loctite, which prevents loosening of the cable support glands.The evaluation of the received information showed that the system was reinstalled on july 15, 2020 by a third party and without the assistance of siemens service.It is assumed that no loctite was reapplied when reinstalling the ceiling screw connection.This led to the screw connection becoming loose due to permanent mechanical stressing.The issue was repaired on site by the customer and without the assistance of siemens service.

• Brand Name: AXIOM ARISTOS FX PLUS
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 10553105
• MDR Text Key: 207558758
• Report Number: 3002808157-2020-46436
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K013826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10093864
• Device Lot Number: 1140
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other