MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-02 for FREEDOM EVO-2 200 10641202 manufactured by Tecan Schweiz Ag.
[15315271]
A laboratory employee was injured when the adjustable front panel door on the instrument fell from an open position. The operator sustained a fracture to elbow and required medical attention at an urgent care facility. The laboratory reported that the front panel was falling very easily from an open position and had fallen several times before on employee's shoulders and head; however, ther had been no injuries. This was the first report to tecan of the problem.
Patient Sequence No: 1, Text Type: D, B5
[15744554]
Tecan received a complaint on (b)(4) 2015 indicating the gas spring that holds the front panel door in an open position and controls the descent was not working as expected. The door panel had fallen injuring an operator. A tecan field service engineer was dispatched and replaced 2 gas springs on the instrument. The gas springs were returned to manufacturer for investigation. The gas springs were greater than 6 years old and were no longer meeting original specification. The investigation concluded that the gas springs had exceeded expected lifetime. The instrument model involved is the worst case configuration (i. E. Heaviest front panel and added dust cover). A remedial action will be initiated to replace all gas strips on the evo 200 instruments older than 3 years with the worst case configuration. Additional corrective action to update tecan service directions to replace gas springs on all evo instruments on a 3 year cycle as part of routine preventive maintenance will be implemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003402518-2015-00002 |
| MDR Report Key | 4660252 |
| Report Source | 05 |
| Date Received | 2015-04-02 |
| Date of Report | 2015-04-02 |
| Date of Event | 2015-03-10 |
| Date Mfgr Received | 2015-03-10 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2015-04-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR ALEXANDER KREIG |
| Manufacturer Street | 103 SEESTRASSE |
| Manufacturer City | MAENNEDORF ZUERICH 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8708 |
| Manufacturer Phone | 449228560 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM EVO-2 200 |
| Generic Name | PIPETTING STATON FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2015-04-02 |
| Catalog Number | 10641202 |
| 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 | 1. Required No Informationntervention | 2015-04-02 |