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

Model Number	1604788
Medical Device Problem Codes	Unintended Movement (3026); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report that operating table trusystem 7000 had an unintended movement when raising the table.It was noted when resetting the table, it dropped to the floor.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Additional Manufacturer Narrative
No problem found and no parts needed.The event log was retrieved for further analysis.According to the event log records, the table was switched off on (b)(6) 2026, and was not switched back on until (b)(6) 2026, when it was set to service mode¿the same day the technician was on-site and retrieved the event log.On (b)(6) 2026, the error° <5°" appears two times in the event log (cmd_stmsg_tmperr1_angle_error1) while the table top is being adjusted in trendelenburg movement.This indicates that the running gear was lifted off the ground due to a collision with a foreign object.The angle of the column does not change during intended use and the column is perpendicular to the floor 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.In the log file it's seen the angle error occurs immediately after pressing certain button on the remote control, increases from 2° to 5°, and disappears after again to 0°, during the table operations or after a while.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.The safety instruction in the user manual warning the user on the transport/repositioning of the device: -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.-monitor the patient's position.When the zero position is approached on the operating table, inclined patient positions may become steeper than they were before the movement began.

• Brand Name: TS 7000
• 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 ; 2242705355
• MDR Report Key: 24872612
• Report Number: 3007143268-2026-00026
• Device Sequence Number: 10019676
• Product Code: GDC
• UDI-Device Identifier: 00887761967526
• UDI-Public: (01)00887761967526
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: Other
• Device Model Number: 1604788
• Device Catalogue Number: 1604788
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 06/16/2026
• 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