FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1012278
·
Received February 6, 2008
Report
- Report Number
- 9616240-2008-00010
- Event Type
- Malfunction
- Date Received
- February 6, 2008
- Manufacturer
- GAMBRO DASCO S.P.A., MONITOR DIVISION
- Product Code
- FID
- PMA / PMN Number
- K001156
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
IMPROVEMENTS TO INCREASE THE ROBUSTNESS OF THE HYDRAULIC CONNECTORS HAS BEEN APPROVED BY GAMBRO DASCO AND WILL BE IMPLEMENTED IN THE FIELD. THIS EVENT IS BEING REPORTED AS "MALFUNCTION" UNDER THE MDR 2-YEAR RULE, REGARDLESS OF ANY PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | FID | GAMBRO DASCO S.P.A., MONITOR DIVISION | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |