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

Model Number	A-711000-US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the allen supine access top needed to be replaced.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.The allen advanced table is used in positioning patients for surgical procedures.The device's settings or its positions can be controlled using its connected electronic pendant or the table can also be manipulated manually and thus can be continued to be used even if the electronic pendant ceases to function.The technician replaced the allen supine access top to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report stating that when the allen advance table was flipped, the allen supine access top accessory fell off of the table during an in-service inspection.The surgical table was located at the account and occurred before patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: ALLEN
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM MEXICO; ave.del telefono; no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24831827
• Report Number: 3006697241-2026-00130
• Device Sequence Number: 18438584
• Product Code: GDC
• UDI-Device Identifier: 00615521003012
• UDI-Public: (01)00615521003012
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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-711000-US
• Device Catalogue Number: A-711000-US
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/09/2026
• 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