MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-21 for GENESIS FE500 10620400 manufactured by Tecan Schweiz Ag.
[50918172]
Tecan service visited the laboratory on 07/13/2016 and inspected the door locks. It was confirmed they were installed in the wrong direction. The service engineer removed and installed the door locks correctly and verified the functionality. The last preventative maintenance check for the instrument was evaluated and the door locks were functional at that time. In an abundance of caution, tecan files this report since nonfunctional door locks could create an unsafe condition. A capa has been open to investigate. Follow up information will be provided.
Patient Sequence No: 1, Text Type: N, H10
[50918173]
The laboratory called tecan to request a preventative maintenance for their instrument. The lab mentioned the door locks on the instrument were not installed correctly. As a result, when the door is open, the instrument was not turning off. The lab requested a repair. The lab confirmed there were no injuries or no near misses.
Patient Sequence No: 1, Text Type: D, B5
[55104276]
Capa investigation concluded that a tecan field service engineer did not perform and document the required safety test after the replacement of the front panel on june 6th. Root cause was identified as human error. The field service engineer was trained however did not follow the service instructions. This is an isolated event. Corrective action, including the retraining of field service engineer has been implemented
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003402518-2016-00004 |
| MDR Report Key | 5811496 |
| Date Received | 2016-07-21 |
| Date of Report | 2016-09-20 |
| Date of Event | 2016-06-22 |
| Date Mfgr Received | 2016-06-22 |
| Date Added to Maude | 2016-07-21 |
| 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 BARBARA JERONCIC |
| Manufacturer Street | SEESTRASSE 103 |
| Manufacturer City | MAENNEDORF, Z 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8708 |
| Manufacturer Phone | 1449228487 |
| Manufacturer G1 | TECAN SCHWEIZ AG |
| Manufacturer Street | SEESTRASSE 103 |
| Manufacturer City | MAENNEDORF, Z 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8708 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENESIS FE500 |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2016-07-21 |
| Model Number | 10620400 |
| 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 | SEESTRASSE 103 MAENNEDORF, Z?RICH 8708 SZ 8708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-21 |