MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG TRUSYSTEM 7500 SF; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1717020
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided in a final report.
Event or Problem Description
The customer alleged that the operating table column dropped down with the patient on the table top.This occurred after the surgical procedure when the patient should be removed from the or.The height adjustment of the column doesn't work anymore.No harm or injury to patient or caregiver was reported.This report was filed in our complaint handling system as complaint (b)(4).
Event or Problem Description
The customer alleged that the operating table column dropped down with the patient on the table top.This occurred after the surgical procedure when the patient should be removed from the or.The height adjustment of the column doesn't work anymore.No harm or injury to patient or caregiver was reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
During on-site investigation of the surgical table a defect main lift spindle was identified.The defect spindle was replaced and the function of the surgical table checked prior release for further use.The defect main lift spindle was returned to the manufacturers plant for supplementary investigation.It was noticed a part was broken which allowed the surgical table to drop as described within the initial allegation from the customer.Tests confirmed the spindle broke by tensile stress.During the intended use of the surgical table a tensile force is not anticipated which could lead to the identified defect.The concrete root cause could not be confirmed during the investigation.It is possible that collisions with the floor or other parts caused the breakage.Another possibility as a non-correct service work.The main lift spindle was exchanged in 2016 by a service technician.If the spindle is not correctly adjusted there is a possibility the spindle moves to the mechanical end stop.In this condition it is imaginable that the part can be damaged over time which may lead to the breakage.Both scenarios could no be confirmed during the investigation to have occurred.Based on the findings and as there is no significant trend no further actions are required.

• Brand Name: TRUSYSTEM 7500 SF
• 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: frances coote ; carl-zeiss strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 15673067
• Report Number: 3007143268-2022-00028
• Device Sequence Number: 6421131
• Product Code: GDC
• UDI-Device Identifier: 00887761985865
• UDI-Public: 887761985865
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/08/2023

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: 1717020
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 03/08/2023
• 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