FDA Adverse Event
Malfunction
Summary report: N
9616026-2006-00245
MDR report key: 728499
·
Received June 22, 2006
Report
- Report Number
- 9616026-2006-00245
- 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 INVESTIGATED THE INCIDENT AND THE MACHINE. PROBLEMS HAD PREVIOUSLY BEEN REPORTED SHORT AFTER COMPACT FLASH HAD BEEN REPLACED AND CONNECTIONS VERIFIED. THE FIELD REP WAS UNABLE TO ISOLATE A SPECIFIC CAUSE OF FAILURE. THE FIELD REP REPLACED CARRIER BOARD, PCM ADVANTECH BOARD AND COMPACT FLASH. RELOADED SOFTWARE AND PERFORMED REQUIRED CALIBRATIONS/VERIFICATIONS PER MFR'S PROCEDURES. VERIFIED MACHINE PERFORMED PROPERLY THROUGH MULTIPLE POWER CYCLES AND SALINE RUN. 510(K)# IS K041005
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FII |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |