MAUDE Adverse Event Report: TECAN SCHWEIZ AG FREEDOM EVO 200 MCA; STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

Model Number 30020020

Device Problem Device Fell (4014)

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

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

A tecan fse was dispatched to repair the instrument and replace the gas springs.The gas springs were last replaced in april 2018.The cause of the failure is under investigation and a follow up report will be filed.Although no injuries were reported this mdr is being file an abundance of caution due to prior reports of a similar nature resulting in more serious injuries.

Event Description

The laboratory called for service because the gas spring had failed and the front panel fell and almost hit an operator on the head.The laboratory confirmed no injuries.

Manufacturer Narrative

Upon further investigation of the complaint the tecan service team determined that the malfunction was not caused by a gas spring failure as originally reported.The screw for fixing the gas spring position to the instrument frame became loose and this caused the malfunction.Neither the laboratory nor the field service engineer could determine how the screw became loose.This is an isolated incident and has not be reported to tecan before.The laboratory was able to tighten the screw to secure the gas spring.A tecan field service engineer replaced the gas springs as a precaution.The incident did not lead to death or serious deterioration in the health of a patient or user.The laboratory confirmed no injuries.

Event Description

The laboratory called for service because the gas spring had failed and the front panel fell and almost hit an operator on the head.The laboratory confirmed no injuries.

• Brand Name: FREEDOM EVO 200 MCA
• Type of Device: STATION, PIPETTING AND DILUTING, FOR CLINICAL USE
• Manufacturer (Section D): TECAN SCHWEIZ AG; seestrasse 103; maennedorf, zh 8708 ; SZ 8708
• MDR Report Key: 8377683
• MDR Text Key: 139192734
• Report Number: 3003402518-2019-00001
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 30020020
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1