MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-01-06 for SENSEI X 08257 manufactured by Hansen Medical.
[5309658]
The system fault occurred during a procedure.
Patient Sequence No: 1, Text Type: D, B5
[12652356]
The system fault occurred during a procedure. The system detected a potential hardware issue that would require a reboot to clear the message. The customer continued the case with a manual approach. No patient injury was reported and the system responded as designed when detecting a fault condition. Subsequent to the initial evaluation, additional review determined that in this specific case, the error message was incorrectly activated and no actual hardware fault existed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006026430-2015-00001 |
| MDR Report Key | 4398285 |
| Report Source | 05,07 |
| Date Received | 2015-01-06 |
| Date of Report | 2015-01-06 |
| Date of Event | 2014-03-18 |
| Date Mfgr Received | 2014-03-18 |
| Device Manufacturer Date | 2010-09-30 |
| Date Added to Maude | 2015-01-22 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSEI X |
| Generic Name | SENSEI X ROBOTIC CATHETER SYSTEM |
| Product Code | DXX |
| Date Received | 2015-01-06 |
| Model Number | 08257 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANSEN MEDICAL |
| Manufacturer Address | MOUNTAIN VIEW CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-06 |