MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 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	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that customer was trying to lower the table trusystem 7000 u (dv) and it was not functional.Suddenly, the table dropped 5-6".The bed was located at the account and occurred during a case.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
During on-site investigation, field service technician found that the main lift drive and spindle were damage, bearings inside were falling out when removed.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.Technician replaced the damage main lift drive and damage spindle to resolve the reported event.After the exchange of the drive motor the operating table was working as intended.Although there was no reported injury with this event, if the report of a trusystem 7000 (dv) having an uninteded movement during procedrue were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U DV
• 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; saalfeld, thuringen 7318 ; GM 7318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22318255
• Report Number: 3007143268-2025-00048
• Device Sequence Number: 8819468
• Product Code: GDC
• UDI-Device Identifier: 00887761989719
• UDI-Public: (01)00887761989719
• 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
• Report Date (Section B): 06/24/2025

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: Health Professional
• Device Model Number: 1723633
• Device Catalogue Number: 1723633
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/24/2025
• 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