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

Model Number	1717020
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that during a procedure, stationary column trusystem 7500 was adjusted slightly to trendelenburg, but shortly thereafter, the table automatically adjusted to full trendelenburg.The surgical team managed to prevent the patient from sliding off.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 during a procedure, stationary column trusystem 7500 was adjusted slightly to trendelenburg, but shortly thereafter, the table automatically adjusted to full trendelenburg.The surgical team managed to prevent the patient from sliding off.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
A service technician of baxter¿s distributer inspected the operating table involved in the event at the customer location.The alleged event could not be reproduced; no defect or malfunction was identified.In collaboration with the manufacturer the involved remote control was exchanged and return for further investigation.The analysis of the remote control showed some small damages at the housing and traces of normal handling.A functional test showed no issues or malfunction, the remote control was working as expected.The remote control was disassembled for an optical inspection of the electronics and the other parts inside the housing.There were no abnormalities or defects found during the inspection of the remote control's electronics.A review of the operating tables log file indicated no entries at the time specified by the customer for the event occurred.In summary, no defect could be found that would have caused the table to move unintentionally.Based on this, no further actions are required.

• Brand Name: TS 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: 22611000
• Report Number: 3007143268-2025-00061
• Device Sequence Number: 12108656
• Product Code: GDC
• UDI-Device Identifier: 00887761985865
• UDI-Public: (01)00887761985865(11)220922
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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: Other
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.
• Patient Sex: Unknown