MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PST 500 U; 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	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Baxter is in the process of inspecting the pst 500 u table.There was no allegation of patient or caregiver injury or death reported from this alleged incident.No further information is available on the repair of the bed at this time.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 table was going down by itself.The bed was located at the account.There was no injury, death, or procedural delay reported with this event.
Additional Manufacturer Narrative
During inspection, a visual test and functional was performed.The result was that troubleshooting discovered no issues or errors.Table was reseted.After that, no further issues were found and therefore no action required.Further investigation identified the most likely cause is the hydraulic cylinder failure, which is an understood cause for this problem.A root cause investigation and corrective action will be performed with ncr 3142214.The error can be corrected by replacing the hydraulic cylinder.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 anesthesia through the actual surgery to recovery from anesthesia.The device was investigated thoroughly and the reported issue could not be replicated.No malfunction.Although, the reported event of pst500 moving unnitentionally without user input is likely to cause or contribute death or serious injury.Therefore, baxter considers this event reportable to the fda.
Event or Problem Description
Baxter received a report stating that pst 500 u table was going down by itself.The bed was located at the account.There was no injury, death, or procedural delay reported with this event.

• Brand Name: PST 500 U
• 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; saalfeld, thuringen 7318 ; GM 7318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22336615
• Report Number: 3007143268-2025-00050
• Device Sequence Number: 21086810
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 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: 05/30/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/01/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown