MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-12 for GENESIS FE 500 10352630 manufactured by Tecan Schweiz.
[4628964]
The instrument genesis fe 500 includes a centrifuge (rotanda 46 rsc robotic; catalog #4816-71; manufacturer: (b)(4)). A bucket of the centrifuge serial #(b)(4) broke during the run. Nothing came out of the centrifuge, however, the front panel of the centrifuge blew off. The front panel of the automatic work station in which the centrifuge was integrated was also detached and fell onto the floor right in front of the work station. Nobody was hit or hurt. There was no injuries to any laboratory staff.
Patient Sequence No: 1, Text Type: D, B5
[12149423]
A tecan field service engineer (fse) went onsite and observed centrifuge damage. From observation it appears bucket hanger #3 separated at the pivot point during operation damaging all internal parts of the centrifuge drum area (buckets, rotor, rotor shaft, drum). No pieces were ejected from the containment of the unit; however, residual shock damage to the control and front panel is evident. Damage to the outer casing as well. The front panel of genesis fe 500 instrument did not sustain any damage, however, it was knocked off. Genesis fe 500 has no damage outside processing functions except centrifugation. Damaged centrifuge is being sent to the manufacturer ((b)(4)) for further investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003402518-2014-00004 |
| MDR Report Key | 3953489 |
| Report Source | 05 |
| Date Received | 2014-06-12 |
| Date of Report | 2014-06-11 |
| Date of Event | 2014-05-14 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2014-07-31 |
| 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 Street | SEESTRASSE 103 |
| Manufacturer City | MAENNEDORF, ZUERICH 8708 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8708 |
| Manufacturer Phone | 9228560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENESIS FE 500 |
| Generic Name | PIPETTING STATION FOR CLINICAL USE |
| Product Code | JQW |
| Date Received | 2014-06-12 |
| Returned To Mfg | 2014-06-05 |
| Catalog Number | 10352630 |
| 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 |
| Manufacturer Address | MAENNEDORF, ZUERICH SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-12 |