MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-23 for MIKRO 120 12040-01 manufactured by A. Hettich Gmbh & Co. Kg..
[1297486]
The motor shaft of the centrifuge broke below the rotor, allowing the rotor to spin freely. In so doing, the rotor hit the inside of the centrifuge lid causing it to open. The fixed angle rotor came out of the centrifuge and landed on the lab bench where it stopped spinning. There were no injuries. (b) (4)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015330 |
| MDR Report Key | 1648138 |
| Date Received | 2010-03-23 |
| Date of Report | 2010-03-23 |
| Date of Event | 2009-12-16 |
| Date Added to Maude | 2010-04-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIKRO 120 |
| Generic Name | MICRO CENTRIFUGE |
| Product Code | GHK |
| Date Received | 2010-03-23 |
| Model Number | 12040-01 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A. HETTICH GMBH & CO. KG. |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-23 |