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

Model Number 1429733

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

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

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

The remote control was exchanged and investigated.Visible heat related damage was present at the housing and membrane keypad as a result of impact with a heat generating device.Subsequent electrical testing identified an electrical problem was caused by the heat related damage.After replacing the membrane keypad the remote control and operating table worked as intended.It is unknown what caused the heat damage.

Event Description

A trumpf medical mars operating table began to move after plugging in the cable remote control.The leg sections started moving downwards.No patient impact reported.

• 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: 6954203
• MDR Text Key: 90561014
• Report Number: 3007143268-2017-00022
• 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: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1429733
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2017
• 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