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	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported table unlocked during case.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
Further investigation for the root cause is ongoing and results will be provided within a final report.
Additional Manufacturer Narrative
The field service of baxter performed an onsite investigation at the hospital.The failure "table unlocked during case" couldn¿t be confirmed during the inspection.The table did not physically unlock, and no hazardous situation occurred.A log file review confirmed that the message "unknown floor lock state" appeared on the remote control a few times.This message is a notice to the user to press the locking button again to avoid an unstable situation of the table.In this event, no harm was reported and no hazardous situation occurred.The message is a safety feature of the table to allow the user to react accordingly.Based on this, no further actions are necessary.
Event or Problem Description
Customer reported table unlocked during case.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: 20794438
• Report Number: 3007143268-2024-00072
• Device Sequence Number: 17850796
• Product Code: GDC
• UDI-Device Identifier: 00887761989719
• UDI-Public: 887761989719
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/28/2025

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: 11/06/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/28/2025
• 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