MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MOBILETT ELARA MAX; MOBILE X-RAY SYSTEM

Model Number 11107444

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

The user informed siemens that the mobilett elara max mobile x-ray system started moving on its own without given command.The user did not provide information whether the issue occurred during a patient procedure.No injury or a change in state of health of a person nor any other serious outcome was communicated.The reported event occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.The described issue was reproduced on a test system.It was found that the problem did not occur uncontrollably but with the micro dmg button and any of the micro drive buttons being active.This may have been caused by a short circuit and switches being in contact during system startup.Consequently, it causes system to start to move during startup.However, the movement is limited to slow speed and its total duration is 10 seconds.As soon as the central processing unit (cpu) is ready, it identifies the problem and stops the movement.This behavior and mitigation of movement was confirmed with the test system.This system behavior will be prevented with the software version vf10f planned to be implemented in the field with the update instruction ui xp048/19/p in q2/ 2020.The parts related to this incident were investigated separately at the material testing department.It was found that two of the three spring steel sheets of the push button were defective.So, these spring steel sheets have no automatic resetting which means that they remain in the "pushed position".The spare part consumption of the micro-switches (material number 11363855) shows values above the defined threshold.Therefore, this component is observed by the product specialists for future measures.After replacement of the micro switches at the concerned site, no further issues have been reported from the field.

• Brand Name: MOBILETT ELARA MAX
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 9552744
• MDR Text Key: 191285224
• Report Number: 3002808157-2020-12831
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• PMA/PMN Number: K182639
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11107444
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other