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 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to evaluate and replace the gas springs.A review of preventive maintenance history indicated the last replacement was in february 2016.The springs are required to be replaced every 3 years and so were just coming due for replacement.The fse determined the left gas spring had no resistance or strength left.Both gas springs were replaced as they were due this month.The springs met their expected lifetime.This report, in an abundance of caution, is filed as prior reports of evo 200 front panels falling have cause more serious injuries for which mdrs were filed.

Event Description

Laboratory called to report that the left gas spring had failed and the front panel on an evo 200 instrument fell and was caught by the operator as it was coming down.No injuries occurred.The right hinge was able to secure the panel if held in a fully upright position.A field service engineer was dispatched to replace the gas springs.

• 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
• Manufacturer (Section G): TECAN SCHWEIZ AG; seestrasse 103; maennedorf, zh 8708 ; SZ 8708
• Manufacturer Contact: jillian walker ; seestrasse 103; maennedorf, zh 8708 ; SZ 8708
• MDR Report Key: 8381210
• MDR Text Key: 137950582
• Report Number: 3003402518-2019-00002
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 30020020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1