MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TS 7000; 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	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Upon on-site inspection, baxter field service technician found the foot stamps were worn.The foot stamps were replaced.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of ts7000 table unlocked during a case were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.
Event or Problem Description
Baxter received a report stating that operating trusystem 7000 table floor locks unlocked during a case.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
Correction: h6 & h11 were modified.H6 the following codes were selected: cause investigation: investigation findings c19 and investigation conclusion d14.H11: additional information was obtained during device investigation.During the device inspection, a functional test was performed.The alleged failure of unintended unlocking during surgical procedure could not be confirmed.It can be assumed, that the table did not unlock physically.Only a message was shown on the remote control to lock the device again.This message is displayed prior a physical unlocking will occur that the user is able to react accordingly.This procedure is described within the instructions for use and the user followed these instructions and this case.No hazardous situation occurred.A malfunction was not identified.As a secondary finding, worn foot stamps were identified.This has no impact or causality with an unlocking of the device and will also not lead to a hazardous situation.The worn foot stamps were replaced.Based on this, no further actions are required.

• Brand Name: TS 7000
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl zeiss straã¿å¸e 7-9.; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22567218
• Report Number: 3007143268-2025-00057
• Device Sequence Number: 4021435
• Product Code: GDC
• UDI-Device Identifier: 00887761967519
• UDI-Public: (01)00887761967519(11)190115
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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
• Operator of Device: Health Professional
• Device Model Number: 1723633
• Device Catalogue Number: 1723633
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown