MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM; ·OPERATING TABLE TRUSYSTEM 7000 U

Model Number TS7000 U

Device Problems Mechanical Problem (1384); Device Issue (2379); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

Service evaluated the table via a series of functional checks and found the table to operating as intended.According to the account's biomed department , it is believed the table collided with a machine or piece of equipment during articulation into reverse trendelenburg causing the base to lift.

Event Description

A trusystem 7000 table was being articulated into the reverse trendelenburg position when the staff heard a "pop" and noticed the foot section floor pegs elevated 6 inches off of the ground.This occurred during the surgical procedure with patient on table.No patient impact or delay of the procedure occurred as a result.

• Brand Name: TRUSYSTEM
• Type of Device: ·OPERATING TABLE TRUSYSTEM 7000 U
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; 07318 saalfeld, ; GM
• Manufacturer Contact: steffen ulbrich ; carl-zeiss strasse 7-9; saalfeld, saale 07318 ; GM 07318 ; 6715864140
• MDR Report Key: 6584079
• MDR Text Key: 76024323
• Report Number: 3007143268-2017-00012
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TS7000 U
• Device Catalogue Number: 1604788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1