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

Model Number 1604788

Device Problems Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)

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

Event Date 08/31/2018

Event Type  malfunction  

Manufacturer Narrative

The technician inspected the table and found no issue in relation to the alleged drop.Additionally, the remote control was found to be damaged.The technician replaced the remote and the device operated as intended.A follow-up report will be submitted if any new pertinent information is discovered.

Event Description

A trusystem 7000 operating table was being lowered when the table descended unexpectedly.No injury was reported.

• Brand Name: TRUSYSTEM 7000 U
• Type of Device: OPERATING TABLE
• 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: 7915077
• MDR Text Key: 122162493
• Report Number: 3007143268-2018-00013
• 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: user facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1604788
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1