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 Collision (1429); Unintended System Motion (1430); Unintended Movement (3026)

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

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation of this allegation is still ongoing.A follow-up report will be submitted once a final resolution has been reached.

Event Description

The customer reported that a trusystem 7000 dv operating table experienced an unintended drop while a patient was on the table which caused damage to the cladding.No injuries were reported.

Manufacturer Narrative

A hillrom service technician inspected the operating table and retrieved its table event logs.Analysis of the logs indicated that the operating table most likely collided with an unknown object in the operating room, which resulted in the unintended drop.Several log entries show the base of the table lifted from the floor at one side during the movement in the antitrend elenburg direction, which is only possible if the table top collides with an object.The hillrom technician thoroughly inspected the operating table and was unable to duplicate the unintended drop reported by the customer.The table functioned as designed.Therefore, the unintended movement was most likely the result of use error.Based on this information, no further action is required.

• 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
• MDR Report Key: 9627295
• MDR Text Key: 202412702
• Report Number: 3007143268-2020-00001
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1723633
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1