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

Model Number 1841083

Device Problems Device Slipped (1584); Unintended Movement (3026)

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

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer alleged that during use of a trusystem 7000, the or tabletop was tilted 5 degrees and additionally chassis tilted with two wheels in the air.It was confirmed there was no injury from the event.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 alleged that that during use of a trusystem 7000, the or tabletop was tilted 5 degrees and additionally chassis tilted with two wheels in the air.It was confirmed there was no injury from the event.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

According to the customer a patient was on the table and the user tilted the tabletop to the left using the control unit of the operating table.At 5 degree tilt left of the tabletop the chassis of the operating table tilted also, two wheels/feet¿s on the right side lifted from the floor.The customer confirmed that the table was stable in this condition and did not tilt back and forth.When moving the tabletop back to the center position (0 degree tilt) the wheels also came back to the floor.At further surgical procedures a similar behavior could not be seen.The device was inspected by a field service technician (fst).The initial allegation could not be reproduced when doing the same workflow.The operating table was stable on all four feet¿s and did not tilt.If the operating table will tilt it either will tip over and tilt back.It is not possible that one side of the device come up from the floor and the device will stay at this position.The only possible situation is a collision with foreign objects which will result in lifting one side from the floor.The review of the log files of the device did also not show any failure.A malfunction of the device was not confirmed for this initial allegation.During on-site evaluation the customer also mentioned that within a previous surgical procedure two floor locks (diagonal) were not engaged and the operating table was tilting over the other two feet¿s.This allegation could also not be confirmed during on-site investigation.However, it was recommended to exchange the hydraulic system which is responsible for the floor lock mechanism.A concrete root cause could not be identified.Please note: the second allegation has no relation to the initial allegation.

• Brand Name: TRUSYSTEM 7000 (DV) V
• 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: 16853694
• MDR Text Key: 314384051
• Report Number: 3007143268-2023-00011
• Device Sequence Number: 1
• Product Code: GDC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1841083
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2023
• 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