MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-13 for PRISMAFLEX manufactured by Gambro Renal Products, Inc..
[47204035]
Patient Sequence No: 1, Text Type: N, H10
[47204036]
Prisma machine screen went white; nothing visible, machine continued to run.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5719814 |
| MDR Report Key | 5719814 |
| Date Received | 2016-06-13 |
| Date of Report | 2016-05-20 |
| Date of Event | 2016-01-27 |
| Report Date | 2016-05-20 |
| Date Reported to FDA | 2016-05-20 |
| Date Reported to Mfgr | 2016-05-20 |
| Date Added to Maude | 2016-06-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLEX |
| Generic Name | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
| Product Code | MDP |
| Date Received | 2016-06-13 |
| Model Number | PRISMAFLEX |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC. |
| Manufacturer Address | 9540 MAROON CIRCLE FLOOR 4 ENGLEWOOD CO 80112 US 80112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-13 |