MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION OPERATING TABLE TRUSYSTEM 7000 U (DV)

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	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Emdr previously submitted under incorrect cfn/fei number 1416980-2025-01679.This emdr is now being resubmitted under the correct cfn/fei number.Further investigation for the root cause is ongoing and results will be provided within a final report.
Event or Problem Description
It was reported that the trusystem 7000 u (dv) had an issue, table shut off in the middle of a surgery while in the trendelenburg position.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
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.During on-site inspection, the technician was able to find the source of the issue in fluid residue on main control board.Technician found also that the enclosure cover was physically bent allowing liquid to leak onto mcb board.After replacement of the motor controller board the table functioned as designed.Based on this information, no further action is required.Although there was no reported injury with this event, if the report of table shuting off in the middle of a surgery were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.
Event or Problem Description
It was reported that the trusystem 7000 u (dv) had an issue, table shut off in the middle of a surgery while in the trendelenburg position.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U (DV)
• Common Device Name: OPERATING TABLE TRUSYSTEM 7000 U
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl zeiss strasse 7-9; saalfeld, thuringen 7318 ; GM 7318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21754518
• Report Number: 3007143268-2025-00036
• Device Sequence Number: 15509079
• Product Code: GDC
• UDI-Device Identifier: 00887761989719
• UDI-Public: (01)00887761989719(11)170227
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/26/2025

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: 1723633
• Device Catalogue Number: 1723633
• 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: 03/18/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2017
• 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