MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH YSIO X.PREE; SYSTEM, X-RAY, STATIONARY

Model Number	11107464
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer¿s inhouse engineer stated that during an ortho examination at the bucky wall stand (bws) the overhead tube locks in directly in front of the room door and will block the only room exit.There was no patient or user incident associated with this case.The service engineer discussed several options for workarounds to relocate the tube in case it needs to be moved out of the way quickly.The workarounds discussed may assist with quickly releasing the tube and allowing it to be moved away from the exit.The inhouse engineer is concerned that in case of an emergency, this may pose a safety risk if the staff cannot easily remember which steps to follow.The inhouse engineer would prefer to simply move the tube with handles utilizing all-lock release buttons.The issue is caused by the unique room planning.For stability reasons it is normal behavior of the system that during an ortho acquisition movements in longitudinal or transverse direction are blocked.Nevertheless, the user has the possibility of moving the tube stand upwards or downwards with a force of 200n in an emergency case.Upward direction would be favorable, because if moving it downwards, the telescope might be in the way.It is currently unclear if the room exit would be unblocked even if the tube stand would be moved completely upwards.It is assumed that in an emergency event, a serious injury might occur if the personnel are not able to move the 3d stand out of the way quickly enough because the system cannot be unlocked for manual movement in longitudinal or transverse direction while performing ortho studies at the wall bucky.Movement of the tube stand in upward direction is not blocked during ortho examinations.No system failure or malfunction was determined.
Additional Manufacturer Narrative
H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: immediate corrective action was not deemed necessary.No system malfunction or failure was determined.As of the date of the manufacturer¿s awareness, siemens healthcare has not been made aware of any previous instances where a person was injured because the tube stand could not be moved out of the way quickly enough.The investigation is ongoing.Manufacturers preliminary analysis: no system malfunction or failure was determined.For stability reasons it is normal behavior of the system that during an ortho study the manual movements in longitudinal and transverse directions are blocked.Movement in vertical direction is not blocked.Issue is related to room planning.A supplemental report will be submitted if additional information becomes available upon the completion of the investigation.
Event or Problem Description
Additional information: additional information was received on (b)(6) 2023, stating that the in-house engineer conducted further tests.When the tube is locked in place as described, it is not so close to the doorway that it completely prevents the door from opening, as initially reported by staff.It was confirmed that even with the tube locked in place, the main door to this x-ray room can be opened and a stretcher or wheelchair can be moved through if necessary.It could not be confirmed that the door was blocked by the tube.Based on this information, it was concluded that there was no hazardous situation.The issue is no longer considered as reportable.
Additional Manufacturer Narrative
Additional information received stated that the initially received complaint was not correct and that there was no door blockage.Siemens requests to rescind the initial mdr submitted to the fda on (b)(6) 2023, as this issue is not reportable.
Additional Manufacturer Narrative
The described issue was investigated in detail.The described issue was investigated.It was stated that during an ortho acquisition on the bucky wall stand (bws), the tube stand would inevitably be in front of a room door due to the size of the room and the resulting positioning of the system.In the worst case, the room door could be blocked in case of an emergency.No pictures of the room or the room plan have been provided.A workaround for emergency situations was requested to unlock the tube stand once it is locked and set up for an ortho acquisition.For stability reasons, it is a normal behavior of the system to block movements in longitudinal or transverse direction during an ortho acquisition.It is therefore not possible to move the tube stand.Nevertheless, the user has the possibility of moving the tube stand upwards or downwards with a force of 200n in an emergency.After further clarification, the situation as originally described could not be confirmed.Contrary to what was originally reported, the affected room has two doors.Therefore, the room can be left even in case of an emergency during an ortho examination.It was confirmed that when the tube is locked in place as described, it is not so close to the doorway that it completely prevents the door from being opened.Even in this situation, it is possible to open the main door to the x-ray room and move a stretcher or wheelchair through if necessary.Since no system malfunction was identified the complaint is closed without further measures.H10: siemens healthcare requested that the initial report submitted on august 8, 2023, be rescinded as not reportable based on additional information reported in supplemental report 1 submitted on september 8, 2023.However, an investigation was completed, and siemens healthcare determined that the results of the investigation should be submitted to the fda although the event is not considered reportable.

• Brand Name: YSIO X.PREE
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17480692
• Report Number: 3004977335-2023-00081
• Device Sequence Number: 18314109
• Product Code: KPR
• UDI-Device Identifier: 04056869232904
• UDI-Public: 4056869232904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2023

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: 11107464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 08/17/2023; 08/17/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/08/2023; 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown