MAUDE Adverse Event Report: TECAN SCHWEIZ AG FREEDOM EVO 100; PIPETTING STATION FOR CLINICAL USE

Model Number 10641100

Device Problems Misassembled During Installation (4049); Misassembly During Maintenance/Repair (4054)

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

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

A tecan field service representative (fse) was dispatched to evaluate the report of the front panel falling.The fse replaced the gas spring as it was past the expected lifetime (i.E.3 years).Additionally, the fse installed a second gas spring on the front panel.Based on the upgrade configuration of the evo 100, a front panel with an adjustable shield requires 2 gas springs as specified in the service manual.At the time the instrument was upgraded by field service, only one gas spring was installed in error.A capa has been opened to investigate the issue.The evo 100 front panels are made of plexiglass and are light (3kg) and have been assessed in the past to not cause a serious injury.However, in an abundance of caution, due to prior events on larger and heavier, though similar models that resulted in moderate injuries (and for which mdrs were filed), a mdr is being filed.

Event Description

The laboratory called to report that the door hinges collapsed and the front panel hit the operator on the head.There were no injuries (e.G.Bumps, bruises, cuts, etc) and no medical attention required.There was only one hinge from installation.

• Brand Name: FREEDOM EVO 100
• Type of Device: PIPETTING STATION FOR CLINICAL USE
• Manufacturer (Section D): TECAN SCHWEIZ AG; seestrasse 103; maennedorf, zh 8708 ; SZ 8708
• Manufacturer Contact: jillian walker ; seestrasse 103; maennedorf, zh 8708 ; SZ 8708
• MDR Report Key: 8178748
• MDR Text Key: 131490063
• Report Number: 3003402518-2018-00002
• 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
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10641100
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2014
• 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