SENSEI X 08257

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-12-09 for SENSEI X 08257 manufactured by Hansen Medical.

Event Text Entries

[16001382] A monitor bumped into the suj and knocked it off of the bed rail. The suj fell onto other equipment near the bedside. The system was not in use at the time and no injuries were reported.
Patient Sequence No: 1, Text Type: D, B5

[16019977] The sensei system was not in use at the time. No injuries were reported.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3006026430-2014-00014
• MDR Report Key: 4340027
• Report Source: 05,07
• Date Received: 2014-12-09
• Date of Report: 2014-12-08
• Date of Event: 2014-08-18
• Date Mfgr Received: 2014-08-18
• Device Manufacturer Date: 2013-10-10
• Date Added to Maude: 2014-12-24
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: RICK ALLEN, SR, DIRECTOR
• Manufacturer Street: 800 E. MIDDLEFIELD RD
• Manufacturer City: MOUNTAIN VIEW CA 94043
• Manufacturer Country: US
• Manufacturer Postal: 94043
• Manufacturer Phone: 6504042731
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SENSEI X
• Generic Name: SENSEI X ROBOTIC CATHETER SYSTEM
• Product Code: DXX
• Date Received: 2014-12-09
• Model Number: 08257
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HANSEN MEDICAL
• Manufacturer Address: MOUNTAIN VIEW CA US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-12-09