MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM 7000 DV

Model Number 1723633

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

A trumpf medical service technician was dispatched to investigate the incident and found that fluid had gotten into the rc port and damaged the motor control board.The motor control board and keyboard were replaced, and the table operated as intended.

Event Description

A user facility alleged that a trumpf medical trusystem 7000 dv operating table could not be moved with the remote or column controls while a patient was positioned on the table top.The emergency override would not activate.

• Brand Name: TRUSYSTEM 7000 DV
• Type of Device: 7000 DV
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• MDR Report Key: 7574894
• MDR Text Key: 110587641
• Report Number: 3007143268-2018-00007
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1723633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1