MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-02-20 for NIOBE MAGNETIC NAVIGATION SYSTEM 001-006100-1 manufactured by Stereotaxis, Inc..
[1205478]
During an electrophysiology procedure, a biomedical technician called to report magnetic vector changes to approximately the 7:00 position without intentional input from the user. The vectors were corrected and the procedure continued. The vector change occurred a third time, moving to the same 7:00 position, this time during an rf energy application. The physician immediately discontinued the rf application. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[8461837]
The investigation of this event revealed that the signal for the magnetic vector originated at the touch screen located in the procedure room. An examination of the touch screen revealed the presence of a large scratch in the surface of the screen at approximately the 7:00 position. The damage was sufficient to cause intermittent signals to be sent to the magnet positioners, causing the change in vector direction. The touch screen was disconnected, per the customer's request. Evaluation summary: background: evaluation was performed on niobe system ((b)(4)) located at (b)(6). Malfunction was reported whereby the magnetic field vector would intermittently change to the 7:00 position without user input. Evaluation: the niobe log files were retrieved by the navigant software engineering manager and examined. The log files covered the time frame of the reported malfunction. Apparently the input was originating from the touch screen. There were several field applications sent from the touchscreen to niobe from 15:44 to 16:35. The field directions corresponded approx to the 7 o'clock field direction. Other user intended fields were being applied at each of the times that a request came in from the touchscreen, resulting in the observed jump/change in vector direction. A stereotaxis field engineer examined the niobe system at the customer site. A visual inspection revealed a deep scratch on the touchscreen at approximately the 7:00 position. Apparently the scratch was causing the errant vector change because repeated occurrences of the vector changing to the 7:00 position were observed by field engineer. Conclusion: the root cause of the reported malfunction was touch screen damage, presumably caused by customer facility personnel. Note: the damaged touch screen was removed by customer facility personnel. It was not used to perform procedures because it is only used in ic/crt procedures, which are not performed at this user facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003084417-2009-00001 |
| MDR Report Key | 1372752 |
| Report Source | 05,07 |
| Date Received | 2009-02-20 |
| Date of Report | 2009-02-20 |
| Date of Event | 2009-01-26 |
| Date Mfgr Received | 2009-01-26 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2010-01-21 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | TODD DEBAKER |
| Manufacturer Street | 4320 FOREST PARK AVENUE SUITE 100 |
| Manufacturer City | ST. LOUIS MO 63108 |
| Manufacturer Country | US |
| Manufacturer Postal | 63108 |
| Manufacturer Phone | 3146786137 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIOBE MAGNETIC NAVIGATION SYSTEM |
| Generic Name | STEERABLE CATHETER CONTROL SYSTEM |
| Product Code | NDQ |
| Date Received | 2009-02-20 |
| Model Number | 001-006100-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STEREOTAXIS, INC. |
| Manufacturer Address | ST. LOUIS MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-20 |