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

Model Number	1723633
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	02/16/2026
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 operating table trusystem 7000 was not providing any function while activating.The bed was located at the account.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
During the investigation a functional and visual inspection was performed.The result was that the motor control board was not functioning or responding.The cause of the issue was traced to a burnt circuit on the board.The action to resolve the issue was to replace motor control board and push firmware.Based on this information, no further action is required.The trusystem 7000 operating table is intended for the following use: patient positioning during surgery, including anaesthesia induction and recovery from anaesthesia.Task-related patient transfer within the operating theatre.For applications in conjunction with intra-operative imaging (e.G.Ct, mrt, x-ray) with specific table components.Although there was no reported injury with this event, if the report of a total loss of all functions were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.

• 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: 24561332
• Report Number: 3007143268-2026-00013
• Device Sequence Number: 18508280
• Product Code: GDC
• UDI-Device Identifier: 00887761967519
• UDI-Public: (01)00887761967519(11)250918
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/14/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Patient Sex: Unknown