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	10/24/2025
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 or table trusystem 7000 u was not moving with any functions with keypad or remote.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
During the inspection by a baxter field service technician, it was confirmed that the table will not move on any functions with keypad or remote.The cause of the issue was traced to a defective motor and communication controller board.Due to the failure of the controller boards, the table could no longer be operated with the remote control or the column keypad.After replacement of the affected parts the device was working as intended.Due to the age of the surgical table, an age-related failure of the circuit board is conceivable.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: 23539343
• Report Number: 3007143268-2025-00081
• Device Sequence Number: 9531035
• Product Code: GDC
• UDI-Device Identifier: 00887761989030
• UDI-Public: (01)00887761989030(11)130809
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/24/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2013
• 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