MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG OPERATING TABLE TRUSYSTEM 7000 U (DV)

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	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service of baxter performed an onsite investigation at the hospital.The failure "remote or keypad will not articulate the table " couldn't confirmed during the inspection.The affected device was inspected by a service technician and no malfunction was found on the operating table.As an observation the batteries were identified with low capacity, which may have caused the non-working operating table.In case the batteries are empty, the user is able to operate the device with mains power.Empty batteries will also be displayed at the column keypad and by an acoustic signal; the user can react accordingly.This issue would be unlikely to cause or contribute to a death or serious injury if this were to recur.Based on this, no further actions are required.
Event or Problem Description
Customer reported table will not articulate with remote or keypad during case.This report was filed in our complaint handling system as complaint#: (b)(4).
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Event or Problem Description
Customer reported table will not articulate with remote or keypad during case.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U (DV)
• Common Device Name: OPERATING TABLE TRUSYSTEM 7000 U
• 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: 21584091
• Report Number: 3007143268-2025-00022
• Device Sequence Number: 12978737
• 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): 05/13/2025

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: 02/14/2025
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 05/13/2025
• 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