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 |