MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG OPERATING TABLE TRUSYSTEM 7000 U (DV); 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	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device inspection is pending.Further investigation should confirm the root cause.Investigation results will be provided within a final report if new information will become available.
Event or Problem Description
Customer reported table moved during the procedure.This report was filed in our complaint handling system as complaint # (b)(4).
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.The field service of baxter performed an onsite investigation at the hospital.The allegation that the table moved during the procedure could not be confirmed.Most likely the patient shifted on the tabletop due to lack of security by the user.During investigation, the field service technician identified the operating table did not function due to a motor error.The cause of the issue was traced to fluid residue on right leg motor and distribution board.The failure was resolved by exchange of affected motor and the distribution board.Based on this, no further actions are required.Although there was no reported injury with this event, if the report of an unintended movement were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.
Event or Problem Description
Customer reported table moved during the procedure.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U (DV)
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: daniela avila ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 21631055
• Report Number: 3007143268-2025-00025
• Device Sequence Number: 20899498
• Product Code: GDC
• UDI-Device Identifier: 00887761989719
• UDI-Public: (01)00887761989719
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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
• Device Model Number: 1723633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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