MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-16 for APTIO AUTOMATION AP2 manufactured by Inpeco Sa.
| Report Number | 3007494875-2019-00001 |
| MDR Report Key | 8901772 |
| Date Received | 2019-08-16 |
| Date of Report | 2019-09-13 |
| Date of Event | 2019-07-23 |
| Date Facility Aware | 2019-07-23 |
| Report Date | 2019-08-16 |
| Date Reported to FDA | 2019-08-16 |
| Date Reported to Mfgr | 2019-09-04 |
| Date Added to Maude | 2019-08-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APTIO AUTOMATION |
| Generic Name | LABORATORY AUTOMATION SYSTEM |
| Product Code | CEM |
| Date Received | 2019-08-16 |
| Model Number | AP2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INPECO SA |
| Manufacturer Address | VIA TORRACCIA 26 6883 SZ 6883 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-08-16 |