MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG 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	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further investigation for the root cause is ongoing and results will be provided within a final report.
Event or Problem Description
Customer reported table breaks unlocked.No harm or impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).
Event or Problem Description
Customer reported table breaks unlocked.No harm or impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
A product inspection/analysis was not performed as the device was working as intended after the initial allegation was provided to baxter.During follow-up with the customer it was confirmed that the brakes did not physically unlock.There was only a notice on the remote control for an unknown floor lock state.Based on this, a device inspection or repair was considered to be not necessary.The received notice on the remote control is not a device malfunction.It is a message to notify the user prior any critical situation occurs.The user can react accordingly to the notice.Based on this, no further actions are required, and the complaint was determined to not meet the definition of a reportable event.

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U (DV)
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: frances coote ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 21432691
• Report Number: 3007143268-2025-00013
• Device Sequence Number: 4606149
• Product Code: GDC
• UDI-Device Identifier: 00887761989719
• UDI-Public: 887761989719
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/08/2025

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
• Device Model Number: 1723633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 05/08/2025
• 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