MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION OPERATING TABLE TRUSYSTEM 7000 U DV; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1723633
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
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 onsite inspection, baxter field service technician could not replicate the reported failure.Head section was attaching and detaching from the table as expected.It was determined that user placed the head section onto the table incorrectly.Per the ifu, hazard to the patient due to improper attachment is existent.User shall check that the tabletop sections and accessories are securely fastened to the operating table before each use.The spontaneous movement or slipping out of loose elements may occur.Therefore, user should check that all fastening elements are seated properly and tightly.The reported event of trusystem 7000 head section falling off of the table is likely to cause or contribute death or serious injury, and could be contributed to a user error due to end user failing to properly installed the section.Prevention of this type of event is outlined per the ifu as noted above.Although there was no reported injury with this event, it could potentially cause serious injury or death.Therefore baxter is reporting this event.
Event or Problem Description
Baxter received a report stating that or table trusystem 7000 u (dv) ead section fell off of the table during a surgical procedure with a patient on the table.The bed was located at the account and no harm or significant impact to the surgical procedure was reported.

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U DV
• 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 strasse 7-9; saalfeld, thuringen 7318 ; GM 7318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22330871
• Report Number: 3007143268-2025-00049
• Device Sequence Number: 21191223
• Product Code: GDC
• UDI-Device Identifier: 00887761989719
• UDI-Public: (01)00887761989719
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 06/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Patient Sex: Unknown