FDA Adverse Event
Malfunction
Summary report: N
9616026-2006-00239
MDR report key: 728523
·
Received June 22, 2006
Report
- Report Number
- 9616026-2006-00239
- Event Type
- Malfunction
- Date Received
- June 22, 2006
- Product Code
- FII
- PMA / PMN Number
- k041005
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
NO PT INJURY WAS REPORTED. A GAMBRO FIELD REP EVALUATED THE MACHINE AN FOUND THAT DIALYSATE SCALE READ 0 GRAMS AT 0 GRAMS AND 3975 GRAMS AT 5200 GRAMS. THE TECH CALIBRATED AND VERIFIED ALL SCALES; RAN 1/2 HR SIMULATED RUN WITH NO PROBLEMS OR ALARMS; ASKED FOR 100 GRAMS REMOVED AND 103 GRAMS WAS SHOWN ON SCREEN. 510(K)# IS K041005
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FII |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |