MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG TRUSYSTEM 7500; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	4091000
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Event or Problem Description
The customer reported that without pressing any button from the remote control or column keypad, the column lifted up unintentionally.No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).
Event or Problem Description
The customer reported that without pressing any button from the remote control or column keypad, the column lifted up unintentionally.No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The device was inspected on-site by a field service technician.It was determined that the column keypad had an issue and therefore, it was replaced.The exchanged part was returned to the manufacturer for further investigation.The alleged failure could be confirmed during the manufacturer¿s investigation; the column keypad caused the initial allegation of the unintended operating table movement.After the exchange of the column keypad the operating table was working as intended.The identified issue with the column keypad will be further investigated and trended at the manufacturer.Based on this, no further actions are necessary.

• Brand Name: TRUSYSTEM 7500
• 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: 21206341
• Report Number: 3007143268-2025-00003
• Device Sequence Number: 3943616
• Product Code: GDC
• UDI-Device Identifier: 00887761984455
• UDI-Public: 887761984455
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 4091000
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 04/30/2025
• 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