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

Model Number	1604788
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	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that or table trusystem 7000 u (product code 1604788, serial number (b)(6)), surgical table lost all power and function.There was no report of patient injury however, there was a reported ¿long delay¿ in the procedure due to the inability to unlock the table and move it out of the room.Follow up with the customer found that the staff attempted to reposition the table prior to the incision.The staff attempted to troubleshoot, using the remote and resetting the bed by powering off and back on.It was reported that four of the staff lifted the bed and moved the table to the side so the procedure could continue.It was reported by the customer that the delay was estimated to be about 30 minutes.No patient injury was reported, and the patient was transferred to a different table.
Additional Manufacturer Narrative
The trusystem 7000 surgical table is intended to be used for patient positioning during surgery, ranging from anesthesia induction to actual surgery and recovery from anesthesia.The device functions by mains ac power supply, or on its battery backup.The device ifu outlines the risks associated with damaged power cords/accessories.In this event no injury occurred as a result of a delay that was reported by the customer.The patient remained stable, and this occurred prior to the start of the surgical procedure.The patient was moved to an alternate table and the procedure continued.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
During on-site investigation by a baxter field service technician the operating table involved in the event was inspected.The cause of the alleged power and function loss was traced to a loose battery connector.After the connection was seated properly, the table was plugged into the mains power, and the power of the table was restored.The identified failure of the loose battery connection only affects the battery operation of the device.In mains power operation (power cord plugged into a wall outlet), the operating table is still functioning.If the batteries are not charged or becomes empty, the operating table provides visual and acoustical signals that the user is able to take actions (plug in mains power).The device was working as intended after the repair, the root loose connector was probably caused by a previous service event.Based on this, no further actions are necessary.

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U
• 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: 23586249
• Report Number: 3007143268-2025-00083
• Device Sequence Number: 9259945
• Product Code: GDC
• UDI-Device Identifier: 00887761989030
• UDI-Public: (01)00887761989030
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: N/A.
• Patient Sex: Unknown