MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-21 for ORTHO-CLINICAL DIAGNOSTICS AUTOWASH 96 7003007 936380 manufactured by Tecan Austria Ges M.b.h..
[379984]
The instrument reportedly started smoking while it was in use. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2005-50136 |
| MDR Report Key | 595241 |
| Date Received | 2005-04-21 |
| Date of Report | 2005-04-21 |
| Date of Event | 2005-03-23 |
| Date Added to Maude | 2005-04-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO-CLINICAL DIAGNOSTICS AUTOWASH 96 |
| Generic Name | 96-WELL ELISA MICROWELL WASHER |
| Product Code | IFP |
| Date Received | 2005-04-21 |
| Model Number | 7003007 |
| Catalog Number | 936380 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 585069 |
| Manufacturer | TECAN AUSTRIA GES M.B.H. |
| Manufacturer Address | * GROADIG/SAIZBURG AU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-21 |