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

Model Number 1841048

Device Problem Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2023

Event Type  malfunction  

Manufacturer Narrative

Inspection of the device is pending and results will be provided by a final report.

Event Description

The customer reported that brakes unlocked during surgical procedure.No harm or impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).

Event Description

The customer reported that brakes unlocked during surgical procedure.No harm or impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The device involved in the event was investigated by a field service technician.It could be confirmed that the floor locks (brakes of the operating table) where not working properly.In a first step the floor locks were greased and moved until they were working as intended.In a second step the hydraulic system was exchanged and a software-update was done.The root cause was traced to a failure of the hydraulic system.Based on this, no further actions are required.

• Brand Name: TRUSYSTEM 7000 (MBW)
• Type of Device: 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: frances coote ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 17285752
• MDR Text Key: 319402677
• Report Number: 3007143268-2023-00026
• Device Sequence Number: 1
• Product Code: GDC
• UDI-Device Identifier: 00887761993280
• UDI-Public: 887761993280
• Combination Product (y/n): N
• Reporter Country Code: RO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1841048
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1