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

Model Number 7000 U

Device Problems Mechanical Problem (1384); Unintended System Motion (1430); Device Issue (2379); Physical Property Issue (3008); Unintended Movement (3026)

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

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

Service evaluated the table via a series of functional checks and found the table to operating as intended.Table data logs have been pulled for evaluation.If new relevant information becomes available following the evaluation of the data logs, a follow up report will be submitted.

Event Description

A trusystem 7000 table was being articulated into the trendelenburg position when the staff noticed the base elevated 6 inches off of the ground.

• 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: 6486694
• MDR Text Key: 72804627
• Report Number: 3007143268-2017-00009
• 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,user f
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7000 U
• Device Catalogue Number: 1604788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• 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