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

Model Number	10762470
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers was made aware of a potential product problem associated with the ysio max system.The user stated that the movement of the bucky wall stand is not blocked when either of the two emergency stop buttons on the bucky wall stand are pressed.There was no user or patient injury associated with this issue.It is assumed that in a worst-case scenario, a minor to serious injury might be the outcome if the emergency stops cannot be activated in an emergency situation.
Additional Manufacturer Narrative
H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: no general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: the cause for the issue is not understood yet.The investigation is ongoing.A supplemental report will be submitted if additional information becomes available upon completion of the investigation.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.It was stated that both emergency stop buttons at the bucky wall stand (bws) were not working.The investigation at the customer site showed that the connector for the emergency stop circuit of the bws on the rad connector board socket was incorrectly plugged on the rad-connector board (the rad-connector-board d802 is part of the rad-stand module what is responsible for system movement).Also, a jumper plugged at the socket was found which overwrites the functionality of the mentioned emergency circuit.Therefore, the emergency stop buttons at the bws were without functionality.The last preventive maintenance was performed in june 2023.The analysis of this maintenance protocol indicated that both emergency buttons on the bws were working correctly.It could not be determined when the issue may have been introduced.An individual workmanship error during service intervention is most likely but could not be confirmed.No general problem is known.According to the information received by the service technician, the problem was resolved onsite by connecting the plug for the bws emergency stop circuit into the correct socket of the rad-connector board.In general, it is recommended to the operator to perform a daily check of the emergency buttons.This is also described within the operator manual for ysio max (xpb7-030.620.01.01.02, register 5, system operation ¿ functional and safety check ¿ daily tests, chapter page 8).

• 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: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 19537845
• Report Number: 3004977335-2024-00063
• Device Sequence Number: 17748616
• Product Code: KPR
• UDI-Device Identifier: 04056869004273
• UDI-Public: 04056869004273
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/28/2024
• 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