FDA Adverse Event
Injury
Summary report: N
8010042-2008-00035
MDR report key: 1020250
·
Received March 20, 2008
Report
- Report Number
- 8010042-2008-00035
- Event Type
- Injury
- Date Received
- March 20, 2008
- Product Code
- BSZ
- PMA / PMN Number
- K024213
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER TESTED THE UNIT AFTER THE OPERATION HAD ENDED AND NO FAILURES WERE OBSERVED. INVESTIGATION IS ONGOING. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY MAQUET CRITICAL CARE. MAQUET CRITICAL CARE AB PROVIDES PRODUCT FAILURE INVESTIGATION ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BSZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |