MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for FREEDOM EVO 100 10641100 manufactured by Tecan Schweiz Ag.
[131490063]
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.
Patient Sequence No: 1, Text Type: N, H10
[131490064]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003402518-2018-00002 |
| MDR Report Key | 8178748 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-11-21 |
| Date Mfgr Received | 2018-11-21 |
| Device Manufacturer Date | 2014-11-05 |
| Date Added to Maude | 2018-12-19 |
| 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 Contact | MS. JILLIAN WALKER |
| Manufacturer Street | SEESTRASSE 103 |
| Manufacturer City | MAENNEDORF, ZH 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8708 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FREEDOM EVO 100 |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2018-12-19 |
| Model Number | 10641100 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECAN SCHWEIZ AG |
| Manufacturer Address | SEESTRASSE 103 MAENNEDORF, ZH 8708 SZ 8708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-19 |