MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM 7500; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	4091000
Medical Device Problem Codes	Unintended Movement (3026); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection the service technician was not able to reproduce the alleged malfunction.The investigation is ongoing.Further investigation should confirm the root cause.Investigation results will be provided within a final report if new information will become available.
Event or Problem Description
The customer alleged that the back section of the trusystem 7500 surgical table top suddenly fell down.It was confirmed that there was no harm or injury to patient or caregiver.This report was filed in our complaint handling system as complaint #(b)(4).
Event or Problem Description
The customer alleged that the back section of the trusystem 7500 surgical table top suddenly fell down.It was confirmed that there was no harm or injury to patient or caregiver.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
During investigation of the reported event the following was determined: the field service technician was not able to reproduce the allegation or any product issue during the on-site investigation.The alleged event could not be confirmed, the log files did not show any malfunction or movements of the back section.The device is working as intended.Therefore, no further action is required.

• Brand Name: TRUSYSTEM 7500
• 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: frances coote ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 15263904
• Report Number: 3007143268-2022-00021
• Device Sequence Number: 5871788
• Product Code: GDC
• UDI-Device Identifier: 00887761984455
• UDI-Public: 887761984455
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 4091000
• 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: 08/05/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 10/20/2022
• 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