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

Model Number	4080300
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
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 left leg jacking cylinder and caster detached from table base chasis.No harm or significant impact to the surgical procedure was reported.
Event or Problem Description
Baxter received a report stating that pst 500 u left leg jacking cylinder and caster detached from table base chasis.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
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.A visual inspection was performed from fst onsite.The result was that the wheel with the jack cylinder was separated from the chassie.The cause for this is unknown.The wheel was replaced to resolve the issue.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 caster detached from table base 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: 23619547
• Report Number: 3007143268-2025-00086
• Device Sequence Number: 21077174
• Product Code: GDC
• UDI-Device Identifier: 00887761973671
• UDI-Public: (01)00887761973671(11)250127
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 03/10/2026

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: 4080300
• Device Catalogue Number: 4080300
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 02/15/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.
• Patient Sex: Unknown