FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
MDR report key: 2050113
·
Received April 1, 2011
Report
- Report Number
- 1723170-2011-00568
- Event Type
- Malfunction
- Date Received
- April 1, 2011
- Date of Event
- May 28, 2010
- Report Date
- May 28, 2010
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE COMPUTER WAS REPLACED AND THIS RESOLVED THE ISSUE. THE FAULTY COMPUTER WAS SENT BACK TO THE MFR AND A MOTHERBOARD MALFUNCTION WAS FOUND TO HAVE DIRECTLY CAUSED THE EVENT.
Description of Event or Problem · 1
SITE REPORTED THAT THE FRAME LINK SOFTWARE FROZE ONCE IN REGISTER AND THREE TIMES IN NAVIGATE. THE SYSTEM WAS NON RESPONSIVE. THERE WAS GREEN STATUS WHEN NOT NAVIGATING. THEY HAD TO DO A HARD SHUTDOWN ON EACH OCCASION. THE USER ALSO STATED THAT THE SYSTEM WAS FREEZING WHILE DOWNLOADING THE IMAGES FROM CD. NO IMPACT ON PT OUTCOME REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | TREON | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |