MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-30 for FREEDOM EVO 150 10641150 manufactured by Tecan Schweiz Ag.
[3529829]
Laboratory employee was performing daily maintenance on instrument when the front panel door fell from the open position with the edge of the door striking employee's forehead just above the eye. Employee had a small gash that bled and was treated with basic first aid (cleaning) and application of antibiotic cream and band aid). No further medical attention was required. The employee indicated the door had fallen in the past but no one was injured.
Patient Sequence No: 1, Text Type: D, B5
[10831145]
A field service representative (fse) evaluated the instrument at the customer's laboratory on (b)(4) 2013. The fse was unable to reproduce the event. When the front panel door was lifted all the way open and secured it did not fall. If the door was pushed halfway up, it fell. A gas spring is attached to the door panel and the instrument. The spring aids in maintaining panel in an up position and in controlling the descent. The gas spring was replaced as a precaution and returned to the manufacturer for further evaluation. The gas spring was tested at (b)(4) manufacturing facility and was found to meet specifications. There is no evidence of malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003402518-2013-00002 |
| MDR Report Key | 3144982 |
| Report Source | 05 |
| Date Received | 2013-05-30 |
| Date of Report | 2013-05-30 |
| Date of Event | 2013-04-30 |
| Date Mfgr Received | 2013-04-30 |
| Date Added to Maude | 2013-06-12 |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM EVO 150 |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2013-05-30 |
| Returned To Mfg | 2013-05-01 |
| Model Number | EVO 150 |
| Catalog Number | 10641150 |
| Operator | HEALTH PROFESSIONAL |
| 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 | MAENNEDORF ZUERICH SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-30 |