MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION STATIONARY COLUMN TRUSYSTEM 7500; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1717020
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that stationary column trusystem 7500 was having a total loss of function.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
Baxter is in the process of inspecting the or table.Further investigation is ongoing and all additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Additional Manufacturer Narrative
During on-site investigation the not working operating table could be confirmed.The baxter field service technician performed a reset and the operating table was working as intended.No root cause was identified, no part needed to be exchanged.However, the field service technician updated the firmware to the latest version.A further logfile review indicated several intermittent errors which occurred during the use of the device at the day of the event.A concrete root cause was not identified.According to the instructions for use, in case of a malfunction of the operating table a reset has to be performed.In this case the reset performed by the baxter field service technician solved the temporary issue.Therefore, the user was able to execute the reset and bring the table back to work.Baxter will monitor potential further complaints.Based on this, no further actions are necessary at this time.D4 was updated to reflect the correct udi of the device.Please refer to (b)(4), as the correct information.
Event or Problem Description
Baxter received a report stating that stationary column trusystem 7500 was having a total loss of function.No harm or significant impact to the surgical procedure was reported.

• Brand Name: STATIONARY COLUMN TRUSYSTEM 7500
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22841843
• Report Number: 3007143268-2025-00066
• Device Sequence Number: 4848977
• Product Code: GDC
• UDI-Device Identifier: 00887761985865
• UDI-Public: (01)00887761985865(11)220818
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: 1717020
• Device Catalogue Number: 1717020
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown