MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PST500; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	4080300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Event or Problem Description
Baxter received a report stating that pst 500 u had had brakes not holding.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
H3: correction.A visual and technical inspection was conducted by the technician.It was determined that several rubber feet on the operating table were damaged or missing.This can compromise the table¿s stability, causing it to slip depending on the floor surface.The customer may perceive this as unintended or unintended movement.The technician replaced all four jack cylinders.The medical device pst 500 is a mobile and configurable operating table, which is intended to be used in combination with specific tabletop sections, pads and accessories for patient positioning on the operating table during surgery, from the induction of anaesthesia through the actual surgery to recovery from anaesthesia.Although there was no reported injury with this event, if the report of a unintended movements were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.

• Brand Name: PST500
• 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 strasse 7-9; null; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24393160
• Report Number: 3007143268-2026-00009
• Device Sequence Number: 21458809
• Product Code: GDC
• UDI-Device Identifier: 00887761973671
• UDI-Public: (01)00887761973671
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 4080300
• Device Catalogue Number: 4080300
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/21/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown