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

Model Number	1723633
Medical Device Problem Codes	Sparking (2595); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
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.During on-site inspection, baxter technician found the integrated plug and housing broken.It was determined that most likely when pulling on connection lead.User error.Baxter technician replaced the integrated plug and housing to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report stating that operating table trusystem 7000 plug-in port was ripped and completely unhoused, generating some sparks when plugged in.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• 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 strasse 7-9; null; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22896528
• Report Number: 3007143268-2025-00070
• Device Sequence Number: 14931710
• Product Code: GDC
• UDI-Device Identifier: 00887761967519
• UDI-Public: (01)00887761967519(11)210223
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/26/2025

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: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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