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	10/09/2024
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 alleged that their ts7000 dv surgical table has no function and will not operate.This report was filed in our complaint handling system as complaint #(b)(4).
Event or Problem Description
The customer alleged that their ts7000 dv surgical table has no function and will not operate.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
An investigation was performed by the technician.The technician was able to find the source of the issue in fluid residue on main control board and communication board.After replacement of these parts the table functioned as designed.The root caused was traced to a user error as fluid ingress exceeded the ipx4 standard due to incorrect cleaning of the device.According to the ifu, cleaning the operating table with a high-pressure cleaner, steam cleaner or water jet is prohibited.The operating table must not be cleaned mechanically.The cleaned manually with suitable utensils.Based on this, no further actions are necessary.

• 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: 20597134
• Report Number: 3007143268-2024-00060
• Device Sequence Number: 15654558
• Product Code: GDC
• UDI-Device Identifier: 00887761989719
• UDI-Public: 887761989719
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/27/2024

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: 10/09/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 11/27/2024
• 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