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

Model Number	1604788
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
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 tru system 7000 u head section will not stay in place.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
During inspection by a baxter field service technician it was identified that a gas spring was leaking at the head section.The root cause was traced to a component failure.The defect gas spring was exchanged to resolve the problem.After repair, the product functioned as specified.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: 23538689
• Report Number: 3007143268-2025-00080
• Device Sequence Number: 21234915
• Product Code: GDC
• UDI-Device Identifier: 00887761967526
• UDI-Public: (01)00887761967526(11)150520
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/20/2026

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: 11/05/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2015
• 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