MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG OPERATING TABLE TRUSYSTEM 7000 U (DV); TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1723633
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Liver Laceration(s) (1955)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when the trusystem 7000 operating table was put into trendelenburg, the table allegedly dropped making a loud noise and causing the camera to nick the patient¿s liver.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Event or Problem Description
It was reported that when the trusystem 7000 operating table was put into trendelenburg, the table allegedly dropped making a loud noise and causing the camera to nick the patient¿s liver.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
During on-site investigation of the surgical table no damage related to the reported defect was found.Additionally the event log files were reviewed.Several angle errors in the log were found.The concrete root cause could not be confirmed during the investigation.It is possible that the most likely cause of the crash is a collision of the tabletop with another device due to user error.As the reported event could be contributed to a user error, and a serious injury occurred.Baxter considers this event reportable to the authorities.
Event or Problem Description
It was reported that when the trusystem 7000 operating table was put into trendelenburg, the table allegedly dropped making a loud noise and causing the camera to nick the patient¿s liver.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
During on-site investigation of the surgical table no damage related to the reported defect was found.Additionally the event log files were reviewed.Several angle errors in the log.Were found.The concrete root cause could not be confirmed during the investigation.It is possible that the most likely cause of the crash is a collision of the tabletop with another device due to user error.As the reported event could be contributed to a user error, and a serious injury occurred.Baxter considers this event reportable to the authorities.

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U (DV)
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: farnces coote ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 19600738
• Report Number: 3007143268-2024-00028
• Device Sequence Number: 8084497
• Product Code: GDC
• UDI-Device Identifier: 00887761989719
• UDI-Public: 887761989719
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1723633
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 06/04/2024; 06/04/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 08/08/2024; 08/08/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male