MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2015-06-04 for FREEDOM EVO-2 150 30031019 manufactured by Tecan Schweiz Ag.
[5838114]
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.
Patient Sequence No: 1, Text Type: D, B5
[13346440]
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.
Patient Sequence No: 1, Text Type: N, H10
[54910097]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003402518-2015-00003 |
| MDR Report Key | 4824475 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2015-06-04 |
| Date of Report | 2015-06-04 |
| Date of Event | 2015-04-14 |
| Date Mfgr Received | 2015-05-07 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2015-06-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 103 SEESTRASSE |
| Manufacturer City | MAENNEDORF ZUERICH 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8708 |
| Manufacturer Phone | 49228560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM EVO-2 150 |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2015-06-04 |
| Catalog Number | 30031019 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECAN SCHWEIZ AG |
| Manufacturer Address | MAENNEDORF ZUERICH SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-04 |