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

Model Number	1723633
Medical Device Problem Codes	Electrical Shorting (2926); Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
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
Customer reported no functions from remote or display.Customer found fluid coming from the hand pendant connector and also from the inside of the table.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 "no functions from remote or display" was confirmed during the inspection.The trusystem 7000 operating table is intended for the following use: ¿ patient positioning during surgery, including anaesthesia induction and recovery from anaesthesia ¿ task-related patient transfer within the operating theatre ¿ for applications in conjunction with intra-operative imaging (e.G.Ct, mrt, x-ray) with specific table components.The technician found that failure of the operating table functions was due to short circuit on the circuit board motor calculator, caused by the ingress of fluids.In addition, the remote control was damaged by the penetrated liquids and had to be replaced.Based on this no further action is required.
Event or Problem Description
Customer reported no functions from remote or display.Customer found fluid coming from the hand pendant connector and also from the inside of the table.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: 20372148
• Report Number: 3007143268-2024-00053
• Device Sequence Number: 15170709
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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: 09/23/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/08/2024
• 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