MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM; 7000 DV

Model Number TS7000DV

Device Problems Mechanical Problem (1384); Unintended System Motion (1430); Device Issue (2379); Physical Property Issue (3008); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2017

Event Type  malfunction  

Manufacturer Narrative

Trumpf service evaluated the table via a series of functional checks and found the table to be operating as intended.Table data logs have been pulled for evaluation.If new relevant information becomes available following the evaluation of the data logs, a follow up report will be submitted.

Event Description

A trusystem 7000 dv was being placed into reverse trendelenburg when the table unexpectedly dropped approximately 1/2 inch to 2 inches.No patient impact occured as a result.

• Brand Name: TRUSYSTEM
• Type of Device: 7000 DV
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld, saale 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; carl-zeiss strasse 7-9; saalfeld, saale 07318 ; GM 07318
• MDR Report Key: 6829980
• MDR Text Key: 84329980
• Report Number: 3007143268-2017-00021
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TS7000DV
• Device Catalogue Number: 1723633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• 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