FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1000493
·
Received January 22, 2008
Report
- Report Number
- 9616240-2008-00005
- Event Type
- Malfunction
- Date Received
- January 22, 2008
- Manufacturer
- GAMBRO DASCO S.P.A., MONITOR DIVISION
- Product Code
- FII
- PMA / PMN Number
- k001156
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
IMPROVEMENTS TO INCREASE THE ROBUSTNESS OF THE HYDRAULIC CONNECTIONS HAVE BEEN DESIGNED AND VALIDATED AND ARE CURRENTLY BEING INTRODUCED IN THE FIELD TO AVOID THE OCCURRENCE OF TUBING DISCONNECTION. 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 | * | * | FII | GAMBRO DASCO S.P.A., MONITOR DIVISION | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |