FDA Adverse Event
Injury
Summary report: N
9616240-2008-00045
MDR report key: 1150243
·
Received September 4, 2008
Report
- Report Number
- 9616240-2008-00045
- Event Type
- Injury
- Date Received
- September 4, 2008
- Product Code
- FII
- PMA / PMN Number
- K070643
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
BOTH FACILITY'S BIOMEDICAL TECH AND GTS REP INSPECTED THIS PHOENIX MACHINE. THE GTS REP DISCOVERED THAT THE AIR BUBBLE DETECTOR WAS NOT FUNCTIONING PER MFR'S SPECS. THE ABD ASSEMBLY WAS REPLACED, AND AN ABD VERIFICATION TEST PERFORMED WHICH AND WAS DETERMINED TO BE OPERATING ACCORDING TO MFR'S SPECS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FII |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |