MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION OPERATING TABLE TRUSYSTEM 7000 U DV; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1723633
Medical Device Problem Codes	Unintended Movement (3026); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Event or Problem Description
Baxter received a report stating that during a surgical procedure, a operating table trusystem 7000 had lifted one foot off the ground at one end of the table.The customer then reversed the position and the table lowered rapidly.This occurred during patient use.The patient was uninjured, and the procedure was finished without incident.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
During the on-site inspection a visual inspection and function check test was performed.The result was that no active problems found.No active or recurring errors found.Full articulation working.No physical damage found.The device working as intended.When the ts7000 operating table is used as intended, the angle of the column does not change during use and the column is perpendicular to the floor at zero degree (0°).Therefore, the angle error of the column is an indication that the safe standing position of the column has been changed.The angle error of the column of 5° during the table operation with the remote control indicates that the table is collided with a foreign object or with the floor.Trendelenburg button on the remote control, increases from 2° to 5° and suddenly disappears after again to 0°.When the angle error of 5° disappears suddenly and the column goes back to 0°, this indicates that the table slipped off the object or the object was removed.In this case, exactly this behavior could be confirmed in the event log analysis and explains why the table crashed back down to the floor very fast.User manual #7990045_ 2074531 was provided to the customer for safety instructions.Ifu trusystem 7000 transport/repositioning: -always adjust the operating table to the zero position before placing the patient on the tabletop.-risk of collision when adjusting the operating table.Perform all patient repositioning in a controlled and responsible manner.Observe all electrically supported operating table functions and movements closely up to the final position in order to rule out the possibility of any risk to the patient and material damage to the operating table, equipment or furnishings.Potential collisions must be prevented by aborting the function.Pay close attention to ensure that no surgical draping, tubing or other objects come into contact with moveable parts and get caught by them.Pay particular attention to the operating table when lowering, as the operating tabletop may collide with operating accessories beneath it, or it may even contact the floor if it is set in an extreme position.In some circumstances, there is a possible crushing hazard for persons.

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U DV
• 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; null; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23898920
• Report Number: 3007143268-2025-00094
• Device Sequence Number: 5030437
• Product Code: GDC
• UDI-Device Identifier: 00887761989719
• UDI-Public: (01)00887761989719
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 1723633
• Device Catalogue Number: 1723633
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 04/16/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown