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	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation by a field service technician identified a missing foot lock pad which should not be the cause for the allegation.Further investigation for the allegation is currently ongoing.If new relevant information will become available a follow-up report will be provided.
Event or Problem Description
The customer alleged during a case the or-table was moved into reverse trendelenburg and the foot side of the device base came off the ground.No injury was reported in relation to this allegation.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint could not reveal a clear root cause.Considering all facts provided by the customer and the device evaluation by a field service technician, the event is most likely caused by a collision of the tabletop with the floor or foreign equipment.No evidence of a device malfunction or failure was identified.The previous noticed missing foot lock pad had no impact to the alleged tilting/ lifting from the floor of the or-table.Based on this no further action is required.
Event or Problem Description
The customer alleged during a case the or-table was moved into reverse trendelenburg and the foot side of the device base came off the ground.No injury 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
• MDR Report Key: 11789476
• Report Number: 3007143268-2021-00007
• Device Sequence Number: 14530047
• Product Code: GCD
• UDI-Device Identifier: 00887761989030
• UDI-Public: 887761989030
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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: 04/09/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1