MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-28 for FREEDOM EVO 200 MCA 30020020 manufactured by Tecan Schweiz Ag.
[139192734]
A tecan fse was dispatched to repair the instrument and replace the gas springs. The gas springs were last replaced in april 2018. The cause of the failure is under investigation and a follow up report will be filed. Although no injuries were reported this mdr is being file an abundance of caution due to prior reports of a similar nature resulting in more serious injuries.
Patient Sequence No: 1, Text Type: N, H10
[139192735]
The laboratory called for service because the gas spring had failed and the front panel fell and almost hit an operator on the head. The laboratory confirmed no injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003402518-2019-00001 |
| MDR Report Key | 8377683 |
| Date Received | 2019-02-28 |
| Date of Report | 2019-06-05 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-01-29 |
| Device Manufacturer Date | 2009-07-03 |
| Date Added to Maude | 2019-02-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2019-02-28 |
| 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 | 2019-02-28 |