MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION OPERATING TABLE MARS 2.08; UNIVERSAL OPERATING TABLE, ELECTROMECHANICAL

Model Number	1380201
Medical Device Problem Codes	Positioning Failure (1158); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
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 table mars 2.08 back section was stuck in the upright position.Customer stated motor sound like it was turning but nothing was engaging.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
The described products are intended for human medical use only.The mars 2 operating table in conjunction with the tabletop sections and accessories offered and sold by trumpf medical is intended for the following uses: patient positioning during surgery, ranging from anaesthesia induction through actual surgery to recovery from anaesthesia.Patient transportation on the operating tabletop, from a patient transfer system to the operating theatre or from the operating theatre to a patient transfer system.During the investigation a test was performed.The result was that it failed the tests.The cause of the issue is a defective namur sensor.The problem was resolved by replacing the sensor.According to the table's history, the sensor itself had not been replaced before and had therefore been in use for 12 years.Component failure due to hardware defect.A replacement operating table mars was sent to the customer.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 surgical table being stuck in upright position 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 table mars 2.08 back section was stuck in the upright position.Customer stated motor sound like it was turning but nothing was engaging.No harm or significant impact to the surgical procedure was reported.

• Brand Name: OPERATING TABLE MARS 2.08
• Common Device Name: UNIVERSAL OPERATING TABLE, ELECTROMECHANICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER MEDICAL SYSTEMS (SUZHOU) CO. LTD; building no.14; 188 east guangzhou road; taicang city, jiangsu 21540 0; CH 215400
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22800366
• Report Number: 3007143268-2025-00064
• Device Sequence Number: 12840808
• Product Code: GDC
• UDI-Device Identifier: 00887761991606
• UDI-Public: (01)00887761991606(11)131125
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 01/05/2026

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: 1380201
• Device Catalogue Number: 1380201
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2013
• 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.
• Patient Sex: Unknown