MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,08 report with the FDA on 2012-11-09 for FREEDOM EVO-2 100 10641100 manufactured by Tecan Schweiz Ag.
[2927732]
Tecan was notified by distributor in (b)(6) of an error where the liquid handling arm on the evo 100 collided with the wash station during movement along the x axis. Operator reported a spark from the back of the liquid handling arm and instrument was shut down. There was no injury to any personnel or damage to the facility. Evo instrument was no longer operational.
Patient Sequence No: 1, Text Type: D, B5
[10267552]
Tecan evaluated the liquid handling arm noting that the tantal condenser capacitor c41 overheated which resulted in smoke development and destruction of pcb boards. The assembly has been sent to supplier for further investigation. The results from that investigation will be documented in a follow up report. This appear to be an isolated event. There was no facility damage or injury to any laboratory personnel.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003402518-2012-00001 |
| MDR Report Key | 2834953 |
| Report Source | 00,01,08 |
| Date Received | 2012-11-09 |
| Date of Report | 2012-11-08 |
| Date of Event | 2012-10-14 |
| Date Mfgr Received | 2012-10-14 |
| Device Manufacturer Date | 2012-04-04 |
| Date Added to Maude | 2013-02-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. ALEXANDER KRIEG |
| Manufacturer Street | 103 SEESTRASSE |
| Manufacturer City | MAENNEDORF ZUERICH 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8708 |
| Manufacturer Phone | 449228560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM EVO-2 100 |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2012-11-09 |
| Returned To Mfg | 2012-10-31 |
| Model Number | EVO-2 100 |
| Catalog Number | 10641100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-11-09 |