MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION OR TABLE TOP MR NEURO U; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	2064888
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that operating tabletop middle back section was moving down without any user input.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
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.An inspection/troubleshooting was performed via call by baxter's technical service and the hospitals biomed.The issue could not be reproduced, and the device was functioning as designed.The cause of the issue is unknown; a use error cannot be ruled out.Based on this, no further actions are required.
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Event or Problem Description
Baxter received a report stating that operating tabletop middle back section was moving down without any user input.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: OR TABLE TOP MR NEURO U
• 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: 22612578
• Report Number: 3007143268-2025-00060
• Device Sequence Number: 9564810
• Product Code: GDC
• UDI-Device Identifier: 00887761973817
• UDI-Public: (01)00887761973817
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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,Followup
• Report Date (Section B): 08/12/2025

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: 2064888
• Device Catalogue Number: 2064888
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/12/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown