MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-01 for FREEDOM EVO 200 MCA 30020020 manufactured by Tecan Schweiz Ag.
[137950582]
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.
Patient Sequence No: 1, Text Type: N, H10
[137950583]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003402518-2019-00002 |
| MDR Report Key | 8381210 |
| Date Received | 2019-03-01 |
| Date of Report | 2019-03-01 |
| Date of Event | 2019-02-04 |
| Date Mfgr Received | 2019-02-04 |
| Device Manufacturer Date | 2010-12-16 |
| Date Added to Maude | 2019-03-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Manufacturer G1 | TECAN SCHWEIZ AG |
| Manufacturer Street | SEESTRASSE 103 |
| Manufacturer City | MAENNEDORF, ZH 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8708 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FREEDOM EVO 200 MCA |
| Generic Name | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2019-03-01 |
| Model Number | 30020020 |
| 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 | 2019-03-01 |