MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TS 7500; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1717023
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that during the operation, trusystem 7500 table top collapsed without any input from the nursing staff.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Additional Manufacturer Narrative
The surgical 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.During on-site investigation a baxter field service technician exchanged the main lift spindle of the operating table as it was expected this caused the allegation from the customer.After the exchange the device was tested and it was working as intended.A further investigation of the main lift spindle indicated no defect or malfunction.The reported fault could not be reproduced.A root cause was not established.Baxter will monitor potential further complaints.Based on this, no further actions are necessary at this time.
Event or Problem Description
Baxter received a report stating that during the operation, trusystem 7500 table top collapsed without any input from the nursing staff.No harm or significant impact to the surgical procedure was reported.

• Brand Name: TS 7500
• 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; null; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22874958
• Report Number: 3007143268-2025-00068
• Device Sequence Number: 5803158
• Product Code: GDC
• UDI-Device Identifier: 00887761974395
• UDI-Public: (01)00887761974395(11)230921
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 1717023
• Device Catalogue Number: 1717023
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.
• Patient Sex: Unknown
• Patient Weight: 60 KG