MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ALLEN; Table, operating-room, electrical

Model Number	A-71100-US-
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report that allen advance table us had brakes not holding.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The intended users of the allen® advance table (table) are healthcare employees who have been trained to use the product, and who have the physical strength and cognitive skills to operate and control the product.Follow facility safety protocols if an intended user does not have the physical strength or cognitive skills to operate and control the product safely.The table is intended to be used in an operating room environment to support and position patients during surgical procedures.Several types of specialty tops can be attached to the table to permit surgical access and 360° radiolucency for various types of surgical operations.The patient can be secured into various operable positions from the supine, prone, or lateral position.Electronic controls on the table pendant permit the adjustment of table height, angle, tilt, and auxiliary function for the lateral top.The table contains electronic locking casters that permit the table to be moved and locked into position by use of an electronic control on the table pendant.Upon inspection, baxter field service technician determined that the linkage rod was out of adjustment.A repair was completed to the linkage rod; the linkage was adjusted and tighten.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 a movement on the brakes during surgical procedure were to recur, it could potentially cause serious injury or death.Therefore, baxter is reporting this event.

• Brand Name: ALLEN
• Common Device Name: Table, operating-room, electrical
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ALLEN MEDICAL SYSTEMS, INC.; ave.del telefono; no. 200 col. huinala; apodaca, nuevo leon NA 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50216849
• Report Number: 3006697241-2026-00299
• Device Sequence Number: 6098240
• Product Code: GDC
• UDI-Device Identifier: 00615521003012
• UDI-Public: (01)00615521003012
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: Other
• Device Model Number: A-71100-US-
• Device Catalogue Number: A-71100-US-A1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/11/2026
• 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
• Patient Sex: Unknown