MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME 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	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was checked and a possible installation failure of the hydraulic brake system identified.The hydraulic brake system was corrected and the device checked for functionality.Further investigation should review the installation process and confirm the root cause.Investigation results will be provided within a final report if new information will become available.
Event or Problem Description
The customer reported the operating table was on the brakes when starting the surgical procedure.After ten minutes two brakes released and the device was rocking.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
During investigation of the device it was determined that the hydraulic hoses for the brake system were installed in a wrong order.This caused the brake system to not work correctly and following two brakes to release.Prior the described event occurred the hydraulic unit of the device was exchanged by a service technician.The wrong installation of the hoses was done at this service event.The service manual includes a section for the correct installation of the hoses and the exchange of the hydraulic system is also a part of the service training for this device.After the correction of the hydraulic hoses the device was working as intended.The root cause was traced to a human failure - not following the repair instructions.As no similar events are known and based on the above findings no further actions are required.
Event or Problem Description
The customer reported the operating table was on the brakes when starting the surgical procedure.After ten minutes two brakes released and the device was rocking.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): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; carl-zeiss-strasse 7-9; saalfeld/ thueringen 07318 ; GM 07318
• MDR Report Key: 12437992
• Report Number: 3007143268-2021-00014
• Device Sequence Number: 17116547
• Product Code: GDC
• UDI-Device Identifier: 00887761979390
• UDI-Public: 887761979390
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 12/01/2021
• 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