MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH YSIO MAX; STATIONARY X-RAY SYSTEM

Model Number	10762470
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting an investigation of the reported incident.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).
Event or Problem Description
Unintended system movement of the ysio max unit was reported.During preparation for an exam, the operator touched the 3d ceiling stand, and it moved without unexpectedly.The 3d collided with the bucky wall stand.No patient was present in the exam room.There are no injuries attributed to this event.The reported incident occurred in (b)(6).
Additional Manufacturer Narrative
The issue was investigated in detail.During an investigation at the customer site, it was identified that prior to the reported event it was determined that the force sensor was defective and needed to be replaced.The reported event occurred following the discovery of the defect prior to part replacement.In general, it is recommended to take the system out of use as a precaution until the problem is solved.The investigation of the provided log files confirmed that the described issue was caused by a force-controlled movement.The sensor was defective in the z-direction.It was found that during the rotation horizontal axis was rotated from 0 ° to approx.57 °, the defective force sensor received incorrect z values.The user communicated that, as the tube stand was driving the wrong way, the operator wanted to hold it back.The machine detected a manual movement, the automatic stop is in general deactivated for manual movement.This resulted in a collision between tube stand and wall stand.The system provides multiple risk mitigating features, which are still within specs: force limitation of 200n (motor current measurement).Dead man switch - the movement continue only when a button is pressed.Emergency stop - the motor power supply will be interrupted as soon as the button is activated.According to the information received, the force sensor was replaced following the incident.Since the part replacement no further issues are have been reported.The spare part consumption of the concerned force sensor (material number 07042315) shows values that are below the defined threshold.No general problem is known.

• Brand Name: YSIO MAX
• Common Device Name: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; erlangen 91052 ; GM 91052
• MDR Report Key: 11333188
• Report Number: 3002808157-2021-67509
• Device Sequence Number: 16789628
• Product Code: KPR
• UDI-Device Identifier: 04056869004273
• UDI-Public: 04056869004273
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10762470
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other