FDA Adverse Event
Other
Summary report: N
SERVO-S
MDR report key: 3234049
·
Received July 15, 2013
Report
- Report Number
- 8010042-2013-00112
- Event Type
- Other
- Date Received
- July 15, 2013
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K041223
- Report Source
- Distributor report
Narratives
Additional Manufacturer Narrative · 1
FURTHER INFO SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MDR REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. REFERENCE EXEMPTION #: (B)(4).
Description of Event or Problem · 1
REF # IMP (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 325630 | SERVO-S | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |