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	Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Baxter is in the process of inspecting the operating table trusystem 7000.There was no allegation of patient or caregiver injury or death reported from this alleged incident.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
The customer reported they were unable to level the table or go into trend mode.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 field service of baxter performed an onsite investigation at the hospital.The failure "operating table could not be moved" could confirmed during the inspection.It was identified that a drive motor had a defect and the remote control was defect as well.Both were replaced and the device is working as intended.Based on this, not further action is necessary.
Event or Problem Description
The customer reported they were unable to level the table or go into trend mode.No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).

• 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: 21630142
• Report Number: 3007143268-2025-00023
• Device Sequence Number: 15684748
• Product Code: GDC
• UDI-Device Identifier: 00887761989719
• UDI-Public: 887761989719
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: 02/19/2025
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/19/2025
• 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