MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG FLOOR MOUNTING COLUMN TS 7500 U; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1730732
Medical Device Problem Codes	Unintended System Motion (1430); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the trusystem 7500 surgical table dropped one inch during a surgical procedure resulting in unintended movement.There was no injury or procedural delay reported with the event.The trusystem 7500 surgical table is used during surgical procedures to support and position the patient to optimize surgical site access and visibility.During the inspection of the device by a hillrom technician found the device to be functioning as designed, the technician was unable to duplicate any problems or find any logs pertaining to this issue.The technician installed firmware on the device and the device was functioning as designed.In a surgical environment, a steady surgical field/surgical site is imperative.The unexpected/unintended sudden movement of the table could cause movement to the surgical field and site and possibly result in serious injury from surgical instruments in use at the time of the movement (sharp or electrical).Although this event did not result in injury, the reported event is reportable due to the potential for serious injury.The device was functioning as designed.Based on this, no further action is required.
Event or Problem Description
The customer alleged the column dropped 1 inch during a surgical procedure.No harm or impact to the procedure was reported.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: FLOOR MOUNTING COLUMN TS 7500 U
• 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 thuringen 07318 ; GM 07318
• MDR Report Key: 12806990
• Report Number: 3007143268-2021-00016
• Device Sequence Number: 20227694
• Product Code: GDC
• UDI-Device Identifier: 00887761993129
• UDI-Public: 887761993129
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: 1730732
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/12/2021
• 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