MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG OPERATING TABLE TRUSYSTEM 7000 U; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1604788
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing, if further information will become available a follow-up report will be submitted.
Event or Problem Description
The customer alleged no function of the operating table was possible, either from the remote control nor the column keypad.No device reset was possible due to the column was in a too low position.No harm was reported in relation to this allegation.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
During investigation a defect remote control was identified.The remote control was exchanged and the operating table was working as intended according to the customer.It could not be confirmed that the whole operating table did not work.The column keypad was available as an independent control unit in case the remote control is not available or defect.It is believed the user did not use the column keypad correctly, therefore a total loss of function was alleged.To initiate a movement command from the column keypad the green unlock button needs to be pressed prior any movement button.This is different from the remote control and ensures no movement button is pressed unintentionally.The reset button is also available and reachable in case the table is in the lowest position but some efforts to reach the button are necessary in this case.Because of the defect remote control and the inadequate knowledge of the column keypad, a reset would not have helped in the alleged event.Based on this no further action is necessary.
Event or Problem Description
The customer alleged no function of the operating table was possible, either from the remote control nor the column keypad.No device reset was possible due to the column was in a too low position.No harm was reported in relation to this allegation.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 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
• MDR Report Key: 12306607
• Report Number: 3007143268-2021-00013
• Device Sequence Number: 19750529
• Product Code: GDC
• UDI-Device Identifier: 00887761989030
• UDI-Public: 887761989030
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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
• Operator of Device: No Information
• Device Model Number: 1604788
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1