MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG YSIO MAX; SYSTEM, X-RAY, STATIONARY

Model Number	10762470
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	08/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3, h6: initial actions (corrective and/or preventive): no general problem has been detected for the installed base which requires an immediate action.Manufacturer's preliminary results and conclusion: user contribution is currently seen as the main cause for the issue.There is a warning in the operator manual to not position a patient with legs under the table.If additional reportable information is obtained during investigation, a supplemental report will be submitted to the fda.
Event or Problem Description
Siemens healthineers became aware of an event associated with the ysio max system.The customer communicated that while the patient was receiving a wrist examination, the patient stretched out their leg and accidentally hit the foot switch for table movement at the table base with their foot.This resulted in the table being lowered hitting the patient¿s knee.The patient sustained skin abrasions and reported pain.The technician on duty disinfected the abrasions and immediately took an x-ray of the injured area.After reviewing the x-ray, the diagnosing doctor did not find any bone fractures.In a worst-case scenario, if the issue were to recur, serious injury could result from a crushing injury.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed a detailed investigation of the reported problem.It was stated that the patient accidentally hit the foot kick switch for table movement in the table base with their foot.This resulted in a table downward movement which was stopped by releasing the button or by pressing an emergency stop button.It could no longer be determined what finally stopped the movement.The tabletop has an integrated collision protection that stops the downward movement when an obstacle is sensed.This only works for the tabletop and not for the table base frame under which the patient¿s knee was located.In general, patients must not be positioned with legs underneath the table during examination and the table must not be moved while a patient is seated near the table.This is also described within the operator manual xpb7-030.620.01.01.02 (chapter system safety on page 38/60).The investigation did not indicate any system malfunction and there was no unintended movement.The system worked as specified.The complaint was closed.

• Brand Name: YSIO MAX
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1; -or- rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1; -or- rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 22892988
• Report Number: 3004977335-2025-00102
• Device Sequence Number: 12985810
• Product Code: KPR
• UDI-Device Identifier: 04056869004273
• UDI-Public: (01)04056869004273
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10762470
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female