MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. HG JUPITER SM OPERATING TABLE; BATTERY POWERED ELECTROMECHANICAL OPERATING TABLE

Model Number 4003171

Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

According to the investigation, the cause of the table running on its own was damage to the keypad in the remote.This issue is dealt with in the ongoing fsca ((b)(4)).The keypad used was prior to the design change.Trumpf medical has issued safety instructions to the users in the field safety notice and those should be followed until trumpf medical is able to do the final exchange.The operation table and the remote control were checked by service and repaired.Anticipated completion of the fsca is july 2016.

Event Description

Trumpf medical received information stating that a jupiter or trusystem 7500 operating table moved independently and without the user deliberately pressing an operating element.No patients or users were injured.This report was filed in our complaint handling system.

• Brand Name: JUPITER SM OPERATING TABLE
• Type of Device: BATTERY POWERED ELECTROMECHANICAL OPERATING TABLE
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. HG; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318 ; 9367158641
• MDR Report Key: 5037543
• MDR Text Key: 25143723
• Report Number: 9681407-2015-00009
• Device Sequence Number: 1
• Product Code: FWX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Remedial Action: Notification
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4003171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: No
• 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