MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM; MOBILE COLUMN TRUSYSTEM 7500

Model Number TS7500 U

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

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

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

According to the account's biomed department , the table collided with a heater during articulation causing the base to lift.After removing the heater, the operating table was used as intended during the rest of the surgery.

Event Description

A trusystem 7500 table was being articulated to lower the foot end of the table.A heater was positioned below the foot end.When the table top collided with the heater the column began to lift from the floor.No patient impact occured as a result.After removing the heater, the operating table was used as intended during the rest of the surgery.

• Brand Name: TRUSYSTEM
• Type of Device: MOBILE COLUMN TRUSYSTEM 7500
• 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: 6600411
• MDR Text Key: 76503283
• Report Number: 3007143268-2017-00013
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TS7500 U
• Device Catalogue Number: 1454298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2017
• 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