FDA Adverse Event
Malfunction
Summary report: N
PENUMBRA SYSTEM ASPIRATION PUMP 110
MDR report key: 2060787
·
Received March 11, 2011
Report
- Report Number
- 3005168196-2011-00112
- Event Type
- Malfunction
- Date Received
- March 11, 2011
- Date of Event
- February 14, 2011
- Report Date
- February 16, 2011
- Manufacturer
- PENUMBRA, INC.
- Product Code
- BTA
- PMA / PMN Number
- K051758
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN AND A F/U MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.
Description of Event or Problem · 1
DURING A TREATMENT OF AN ACUTE ISCHEMIC STROKE, IT WAS NOTED THAT THE PENUMBRA SYSTEM ASPIRATION PUMP EMITTED A "BURNING" SMELL. THE PUMP WORKED APPROPRIATELY, MAINTAINED PRESSURE AND HAD BEEN ON FOR APPROX ONE HOUR. THE HOSPITAL SWITCHED PUMPS AND CONTINUED THE CASE WITHOUT ANY ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENUMBRA SYSTEM ASPIRATION PUMP 110 | BTA & JCX | BTA | PENUMBRA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |