MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM MOBILE COLUMN; SURGICAL TABLE

Model Number 1717023

Device Problems Computer Software Problem (1112); Mechanical Problem (1384); Application Program Problem (2880); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

During the inspection by the trumpf medical technician, a defective main lift spindle was identified.The spindle was exchanged, and the device was working as designed.The spindle was returned to trumpf medical for evaluation.It was determined that a part inside the spindle broke, causing the issue.Further investigation is ongoing, and a follow up report will be submitted if any new information is discovered.

Event Description

During a procedure, the patient was on the table top and needed to be transferred onto the column.In order to perform the transfer from table top to column, the column needed to be lowered.During this action, the column, without the table top or patient, collapsed.No injury reported.

Manufacturer Narrative

A hillrom service technician performed an on-site investigation of the operating table column and identified the spindle for the main lift was not functioning as designed.The spindle was then investigated at trumpf medical/ hillrom, the supplier, and an external laboratory.No deviations from the product specifications were identified during the investigation.The external laboratory concluded one part of the spindle was broken due to an overload by a tensile force.A tensile force cannot occur during the intended use of the device.Further investigation of the operating table log files identified that the sensors recognized a shuttle was being used at the operating table column at the time of the event.Therefore, the root cause for the malfunctioning spindle was determined to be a known software failure which has previously been investigated.During the transport of the column with the shuttle, the previously investigated software failure can cause the column to move in the wrong direction and collide with the shuttle frame, which may result in a tensile overload.This could potentially lead to breakage of the main lift spindle.The instructions for use state no patient is to be placed on the operating tabletop during column transport with the shuttle.Therefore, there is no risk for patient impact and minimal risk of any injury to a user or third person due to the spindle breakage that may occur during transport of the column with the shuttle.During the current investigation, it was identified the spindle can be damaged prior to patient use through the above described transfer of the column with the shuttle.If the spindle is damaged and placed into patient use, the risk for patient or user injuries during use of the column does exist.This would be noticeable during the required daily visual check or maintenance.Based on this information, no further actions are required at this time.

• Brand Name: TRUSYSTEM MOBILE COLUMN
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• MDR Report Key: 8642140
• MDR Text Key: 147071456
• Report Number: 3007143268-2019-00006
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1717023
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1