MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG OPERATING TABLE TRUSYSTEM 7000 U; SURGICAL TABLE

Model Number	1604788
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon device inspection by a hillrom technician it was identified the main lift spindle is defect.The spindle was exchanged.Once further information is available from the investigation a follow-up report will be submitted.
Event or Problem Description
The customer alleged the operating table trusystem 7000 displayed an error message.Upon further evaluation by the biomed technician the device dropped into the lowest position and could not be raised anymore.No injury was reported.The complaint is registered under (b)(4) in our complaint handling system.
Additional Manufacturer Narrative
The investigation identified a part had separated from the main lift spindle allowing the spindle to no longer hold the position of the operating table which dropped into the lowest position as a result of the failure.It was not possible to identify the root cause for the part separation.The manufacturing data and investigation results indicated no deviations from the specifications.The main lift spindle was exchanged and the operating table is working as intended.Based on this no further action is required.
Event or Problem Description
The customer alleged the operating table trusystem 7000 displayed an error message.Upon further evaluation by the biomed technician the device dropped into the lowest position and could not be raised anymore.No injury was reported.The complaint is registered under (b)(4) in our complaint handling system.

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U
• Common Device Name: SURGICAL TABLE
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 11162723
• Report Number: 3007143268-2021-00001
• Device Sequence Number: 3616470
• Product Code: JEA
• 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): 09/14/2021

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: 12/17/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1