FDA Adverse Event
Malfunction
Summary report: N
SENSEI
MDR report key: 926393
·
Received October 10, 2007
Report
- Report Number
- 3006026430-2007-00001
- Event Type
- Malfunction
- Date Received
- October 10, 2007
- Date of Event
- September 12, 2007
- Report Date
- October 11, 2007
- Manufacturer
- HANSEN MEDICAL, INC.
- Product Code
- DRA
- PMA / PMN Number
- K052480
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A MODIFICATION TO THE SOFTWARE WAS CREATED TO MITIGATE THE ISSUE ENCOUNTERED. THE SOFTWARE WAS RELEASED AND PROVIDED TO ALL SYSTEMS.
Description of Event or Problem · 1
WHILE RESPONDING TO A SYSTEM PROMPT TO "RE-SEAT CATHETER", THE RCM INITIATED AN RCM CALIBRATION ROUTINE, WITH THE CATHETER PARTIALLY ATTACHED TO THE RCM. THE PHYSICIAN REACTED TO THE UNEXPECTED MOTION AND REMOVED THE CATHETER. THERE WAS NO PATIENT INJURY. THE CASE WAS COMPLETED WITH A NEW CATHETER WITHOUT FURTHER INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENSEI | CATHETER CONTROL SYSTEM | DRA | HANSEN MEDICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |