FDA Adverse Event
Malfunction
Summary report: N
9616240-2006-00349
MDR report key: 728468
·
Received June 21, 2006
Report
- Report Number
- 9616240-2006-00349
- Event Type
- Malfunction
- Date Received
- June 21, 2006
- Product Code
- FII
- PMA / PMN Number
- k010805
- Removal / Correction Number
- Z-1545-05
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
NO PT INJURY WAS REPORTED. A GAMBRO TECHNICAL SERVICES (GTS) FIELD REP FOUND IN THE PRISMA HISTORY EVENTS SEVERAL BAG EMPTY/FULL FOLLOWED BY INCORRECT REPLACEMENT WEIGHT CHANGE ALARMS. HE INSPECTED THE MACHINE AND NO PROBLEM WAS FOUND. 510(K)# IS K010805
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FII |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |