MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG OPERATING TABLE TRUSYSTEM 7000 U; SURGICAL TABLE

Model Number	1604788
Medical Device Problem Code	Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
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 that the table functions were not working from the remote or keypad.Put the table into emergency override, no change.This report was filed in our complaint handling system as complaint # (b)(4).
Event or Problem Description
Customer reported that the table functions were not working from the remote or keypad.Put the table into emergency override, no change.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
The inspection of the device concluded fluid ingress damaged electrical parts inside the operating table which led to the loss of function of the device.The cause for the fluid ingress could not be clarified, no manufacturing or design defect was identified.According to the ifu the device may not be cleaned by machine.Cleaning must be carried out by hand using appropriate utensils.The defect electronic components were exchanged and the device is working as designed.Based on this no further information is available.

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U
• Common Device Name: SURGICAL TABLE
• 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: 16713405
• Report Number: 3007143268-2023-00009
• Device Sequence Number: 7171817
• Product Code: GDC
• UDI-Device Identifier: 00887761989030
• UDI-Public: 887761989030
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/09/2023

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: 1604788
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 06/09/2023
• 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