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

Model Number	1723633
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that operating table trusystem 7000 unlocked on its own during procedure.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Event or Problem Description
Baxter received a report stating that operating table trusystem 7000 unlocked on its own during procedure.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
During device inspection by a field service technician a functional and visual test was performed.The test did pass; no defect or malfunction of the device was discovered.Additionally, the log files were checked and an issue identified related to the operating table, a suspect control module.The control module was replaced.The log file was further analyzed by the manufacturer plant and shows no unintended unlocking as alleged.Just during normal unlocking procedure of the table, an error message occurs sporadically.This error message indicates a hardware error in the control module, which does not cause an unintended movement or unlocking.After inspection and replacement of the control module, the table was working es intended.The original allegation of unintended unlocking could not be confirmed.Based on this, no further actions are required.

• 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; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 22591356
• Report Number: 3007143268-2025-00059
• Device Sequence Number: 8995738
• Product Code: GDC
• UDI-Device Identifier: 00887761967519
• UDI-Public: (01)00887761967519(11)220404
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown