MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUSYSTEM 7000 U (DV); OPERATING TABLE

Model Number 1723633

Device Problems Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

A hillrom service technician was dispatched to inspect the trusystem 7000 u (dv).The technician was unable to duplicate the issue; however, it was discovered that the trend drive motor was malfunctioning and would stop moving during the function check.This motor was replaced and the table was recalibrated.The table was verified to operate as intended.A review of the table data logs is currently in progress.A follow-up report will be submitted if any new information is discovered.

Event Description

The customer reported that a trusystem 7000 dv operating table experienced unintended movement during a case which caused the patient to slide on the table top.No injuries were reported.

• Brand Name: TRUSYSTEM 7000 U (DV)
• Type of Device: OPERATING 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: 9712935
• MDR Text Key: 193383848
• Report Number: 3007143268-2020-00002
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1723633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1