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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

A trumpf medical service technician was dispatched to inspect the operating table.A review of the error logs revealed that the table was being used at an unsafe angle which resulted in the lowering of the table.The initial investigation from the technician shows he reset the operating table and it was verified to be functioning as designed.The investigation is still ongoing, and a follow-up report will be submitted if any new pertinent information is discovered.

Event Description

A trusystem 7000 operating table descended unexpectedly during a surgery.No injury was reported.

Manufacturer Narrative

A review of the table's data logs showed that the user moved the table into reverse trendelenburg until the table's sensors indicated an unsafe angle.This indicates that the base was lifted more than 5° from the horizontal position.The logs further show an abrupt change to the horizontal position which can be viewed as "dropping" by the user.Following the incident, the table was used without any further issues.The most likely reason for the behavior is a collision with a foreign equipment during the reverse trendelenburg movement caused by user error.No further actions are necessary based on these findings.

• 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
• MDR Report Key: 8455813
• MDR Text Key: 140154548
• Report Number: 3007143268-2019-00002
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• 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?: Yes
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1