MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG TRUSYSTEM 7000 U14 (MBW); TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	2065385
Medical Device Problem Codes	No Apparent Adverse Event (3189); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
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
The customer reported that brakes disengage.This report was filled in our complaint handling system as complaint # (b)(4).
Event or Problem Description
The customer reported that brakes disengage.This report was filled in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The trusystem 7000 operating table is intended for the following use: patient positioning during surgery, including anaesthesia induction and recovery from anaesthesia.Task-related patient transfer within the operating theatre.For applications in conjunction with intra-operative imaging (e.G.Ct, mrt, x-ray) with specific table components.The field service of baxter performed an on-site investigation at the hospital.The failure "brakes were coming off" was traced to the hydraulic unit.Therefore, the hydraulic unit was replaced.A further investigation at the legal manufacturer identified the most likely cause of the allegation.The table is showing a message on the remote screen if a pressure drop is identified in the hydraulic system which is responsible for the floor locks.This message is displayed before the floor locks are disengaging to notify the user to press the locking button again.It could not be confirmed that the table physically unlocked and only the message was present.The pressure monitoring of the hydraulic unit is a normal safety function to ensure the safe position of the table.As no critical failure was present, this complaint is considered as not reportable.After consideration for potential harms and worst-case scenarios, no serious adverse health consequence would occur from this issue.Based on this, no further actions are required.

• Brand Name: TRUSYSTEM 7000 U14 (MBW)
• 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: daniela avila ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 21514556
• Report Number: 3007143268-2025-00018
• Device Sequence Number: 7901799
• Product Code: GDC
• UDI-Device Identifier: 00887761989719
• UDI-Public: (01)00887761989719
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 06/25/2025

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: 2065385
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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