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

Model Number	1723633
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Event or Problem Description
Customer reported that the dv table was locked into place and the tabletop was twitching although the remote/column controls weren¿t being touched.There was no report of patient injury or procedural delay.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
According to the complaint description, the operating table was jacked locked and the table twitched even though the remote control/column control was not touched.No injuries to patients or staff were reported.The table was inspected by baxter at the customer's site.It was found that all 4 feet on the floor stamps were missing.The entire table would slide/move if pressure was applied due to the missing feet.All four missing feet were replaced and the device was working as intended.It is quite possible that the table could move due to the missing feet, as the floor stamps only stand on the joint balls to which the feet are normally attached.Due to the missing feet, the floor stamps only have a small contact surface and can therefore slide sideways more easily when force is applied to the table.However, the table is still securely locked.It is not possible for the table to tip over or even tip over due to the missing articulated feet.This is because all 4 floor stamps extend evenly on the floor.It was not possible to clearly determine why the feet were missing.Per the ifu the user needs to ensure that the device is undamaged and in a good working order prior each use.Based on this, no further actions are necessary.
Event or Problem Description
Customer reported that the dv table was locked into place and the table top was twitching although the remote/column controls weren¿t being touched.There was no report of patient injury or procedural delay.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U (DV)
• Common Device Name: SURGICAL TABLE
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS 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: 20560094
• Report Number: 3007143268-2024-00058
• Device Sequence Number: 3114121
• Product Code: GDC
• UDI-Device Identifier: 00887761989719
• UDI-Public: 887761989719
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 12/10/2024

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: 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: 10/03/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/10/2024
• 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
• Patient Sex: Unknown