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

Model Number	1604788
Medical Device Problem Codes	Mechanical Jam (2983); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that during a case, the trusystem 7000 table was moving up, the table made a loud sound and no functions were availale after that.No harm or significant impact to the surgical procedure was reported.
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.
Additional Manufacturer Narrative
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.Upon inspection, baxter service technician determined that the high low drive malfunction was due to a broken spindle and a defective high-low drive mechanism.Baxter service technician replaced the high-low drivetrain on the table, set high-low limits and a software update was set.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of a table with no function were to recur, it could potentially cause serious injury or death.Therefore, baxter is reporting this event.
Event or Problem Description
Baxter received a report stating that during a case, the trusystem 7000 table was moving up, the table made a loud sound and no functions were availale after that.No harm or significant impact to the surgical procedure was reported.

• 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 ; 2242702068
• MDR Report Key: 23645758
• Report Number: 3007143268-2025-00089
• Device Sequence Number: 10122797
• Product Code: GDC
• UDI-Device Identifier: 00887761967526
• UDI-Public: (01)00887761967526(11)230726
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/03/2026

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: 1604788
• Device Catalogue Number: 1604788
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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