MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG PST 500; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	4080100
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that after some time hydraulic stamps disengage.It was stated that usually only one stamp loose pressure and table will loose level and start moving on that one stamp.No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Additional Manufacturer Narrative
During remote troubleshooting, baxter technician suggested the distributor's technician to replace the hydraulic unit and the four jack cylinders.The hydraulic unit was exchanged and the device checked for correct functionality.Then it was released for further use.The affected parts were sent for further investigation to the supplier.No loss of pressure in the hydraulic stamps were found and, therefore, the alleged event could not be reproduced.The hydraulic unit was working as intended.The root cause for the reported event could not be identified for sure.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.Based on these findings, this complaint is not considered as a serious incident as no death or a serious deterioration in the state of health of a patient, user or third person is imaginable.Therefore, baxter does not consider this complaint reportable and no further action is required.
Event or Problem Description
Customer reported that after some time hydraulic stamps disengage.It was stated that usually only one stamp loose pressure and table will loose level and start moving on that one stamp.No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: PST 500
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: daniela avila ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 18743751
• Report Number: 3007143268-2024-00007
• Device Sequence Number: 17737364
• Product Code: GDC
• UDI-Device Identifier: 00887761979390
• UDI-Public: 887761979390
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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
• Device Model Number: 4080100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 05/15/2024
• 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