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

Model Number	A-71100
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that allen advance table casters were not holding brake when being locked.The table was located at the account and occurred during biomed testing.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
Several types of specialty tops can be attached to the allen advance 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 allen advance table pendant permit the adjustment of table height, angle, tilt, and auxiliary function for the lateral top.The allen advance table contains electronic locking casters that permit the allen advance table to be moved and locked into position by use of an electronic control on the allen advance table pendant.Upon inspection, baxter technician found the right head caster was not holding and needed to be replaced.The technician replaced the head caster to resolve the reported event.Although there was no reported injury with this event, if the report of a unreliable brake holding capability for unknown reasons were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.

• Brand Name: ALLEN ADVANCE TABLE
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ALLEN MEDICAL SYSTEMS, INC.; 100 discovery way; acton MA 01720
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21575267
• Report Number: 3010216206-2025-00001
• Device Sequence Number: 12869572
• Product Code: GDC
• UDI-Device Identifier: 00615521003012
• UDI-Public: (01)00615521003012
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/11/2025

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: Other
• Device Model Number: A-71100
• Device Catalogue Number: A-71100-US
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2025
• Initial Report FDA Received Date: 03/11/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown