MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-28 for PRISMA UNK manufactured by Gambro.
[20927442]
The department reported pressure alarms involving the filter on the set.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1731653 |
| MDR Report Key | 1731653 |
| Date Received | 2010-05-28 |
| Date of Report | 2010-05-28 |
| Date of Event | 2010-05-17 |
| Report Date | 2010-05-28 |
| Date Reported to FDA | 2010-05-28 |
| Date Added to Maude | 2010-06-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | PRISMA |
| Generic Name | SYSTEM, DIALYSIS MACHINE |
| Product Code | FII |
| Date Received | 2010-05-28 |
| Model Number | UNK |
| Catalog Number | PRISMA |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO |
| Manufacturer Address | 14143 DENVER WEST PARKWAY LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-28 |