MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM; SHUTTLE 3.7 360

Model Number 1459863

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

The trumpf medical service technician that discovered the issue found that it was caused by a missing cover cap which caused the shuttle's bowden cable to come loose.This cable prevents the transfer of the operating table top if the shuttle is in a trendelenburg position.The technician replaced the cover cap and the shuttle is now operating as designed.

Event Description

During an inspection by a trumpf medical service technician, it was discovered that the shuttle would allow the transfer of a operating table top to the column while in trendelenburg position.A transfer in this scenario could lead to the table top falling to the floor.No injury occurred.

• Brand Name: TRUSYSTEM
• Type of Device: SHUTTLE 3.7 360
• 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: 6820364
• MDR Text Key: 83857432
• Report Number: 3007143268-2017-00019
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Model Number: 1459863
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2015
• 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