MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG MARS OPERATING TABLE; SURGICAL TABLE

Model Number 4549310

Device Problems Unintended System Motion (1430); Device Issue (2379); Unintended Movement (3026)

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

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

A service technician inspected the trumpf medical mars operating table and did not find any evidence of an issue, defect, or malfunction.Further investigation is ongoing.A follow-up report will be submitted once new information is available.

Event Description

A trumpf medical mars operating table began to move into a "reflex" position by itself.The table moved to the end position and an acoustic error signal was given.A patient was positioned on the table, but no injuries were reported.

Manufacturer Narrative

A service technician inspected the operating table and did not found any issue, defect or malfunction.During testing, the table operated as intended.Several parts were exchanged to identify the root cause.The investigation of these parts revealed that a mechanical damage to the housing of the remote control most likely led to the described failure mode.The damage is near to the "reflex" button, the same position the table moved in during the unintended movement.Other defects or conclusions for the failure were not identified.

• Brand Name: MARS OPERATING TABLE
• Type of Device: SURGICAL 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: 6833781
• MDR Text Key: 84999206
• Report Number: 3007143268-2017-00020
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4549310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2006
• 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