FDA Adverse Event
Injury
Summary report: N
GEI
MDR report key: 4647988
·
Received March 30, 2015
Report
- Report Number
- 2242352-2015-00238
- Event Type
- Injury
- Date Received
- March 30, 2015
- Report Date
- March 1, 2015
- Manufacturer
- MAQUET CARDIOVASCULAR
- Product Code
- GEI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. INTERNAL COMPLAINT NUMBER - CATSWEB# (B)(4).
Description of Event or Problem · 1
A (B)(6) PHYSICIAN WAS INQUIRING ABOUT CO2 EMBOLUS WITH EVH. IT WAS REPORTED THAT IT WAS SOMETHING THAT THE PHYSICIAN HAD EXPERIENCED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 207998 | GEI | GEI | MAQUET CARDIOVASCULAR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |