MAUDE Adverse Event Report: TECAN SCHWEIZ AG FREEDOM EVO-2 150; PIPETTING STATION FOR CLINICAL USE

Catalog Number 30031019

Device Problem Component Falling (1105)

Patient Problem Abrasion (1689)

Event Date 04/14/2015

Event Type  malfunction  

Event Description

A tecan field svc engineer reported an injury to his supervisor at tecan us on (b)(6) 2015.An internal safety report was completed and forwarded to qa on (b)(6) 2015.The report indicated an injury to a tecan field svc engineer on site at a customer's laboratory working with an evo 150.While working on the pc beside the instrument (left side), the fse opened the safety shield.As he attempted to walk past it, the shield fell down and scrapped his face knocking off the safety glasses he had on.

Manufacturer Narrative

Operating manual version 7.4 demands that the safety shields has to be fully opened.It cannot be excluded that the safety shield was not fully opened and therefore the safety shield fell down.A determination of product malfunction is pending.Tecan is waiting for the return of the original gas springs for eval.A f/u report will be submitted upon completion of eval.The field svc engineer did not require any basic first aid or further medical attention when the event occured.The engineer noticed a scratch on his head when he returned home and reported it to his supervisor at a later date.This mdr is filed based on similar occurrences in the past where more serious injuries had occurred.

Manufacturer Narrative

The field service engineer confirmed at the laboratory site that the old gas spring had not enough force to hold the safety shield in the upright position (180 degrees).The new installed gas spring at the customer site was able to lift the safety shield from the 90 degrees position to 180 degrees position without outside assistance.The aged gas spring (10 years old) contributed to the event.Current version of tecan's preventive maintenance checklist requires exchange of gas springs after 3 years.A malfunction was not confirmed.This is a material aging, wear issue.

• Brand Name: FREEDOM EVO-2 150
• Type of Device: PIPETTING STATION FOR CLINICAL USE
• Manufacturer (Section D): TECAN SCHWEIZ AG; maennedorf zuerich ; SZ
• Manufacturer Contact: 103 seestrasse; maennedorf zuerich 8708 ; 49228560
• MDR Report Key: 4824475
• MDR Text Key: 5838114
• Report Number: 3003402518-2015-00003
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 30031019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2005
• 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
• Patient Outcome(s): Other