FDA Adverse Event
Malfunction
Summary report: N
O-ARM 1000 IMAGING SYSTEM
MDR report key: 1900379
·
Received October 26, 2010
Report
- Report Number
- 1723170-2010-00061
- Event Type
- Malfunction
- Date Received
- October 26, 2010
- Date of Event
- October 13, 2010
- Report Date
- October 13, 2010
- Manufacturer
- MEDTRONIC NAVIGATION
- Product Code
- IZL
- PMA / PMN Number
- K092564
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PT WAS INVOLVED. MEDTRONIC REP COMPLETED AND DOCUMENTED SYSTEM EVAL. THE UNIT WAS SERVICED AND BROUGHT BACK INTO COMPLIANCE. PLEASE SEE ATTACHMENT FOR ADDITIONAL DETAILS OF SYSTEM EVAL.
Description of Event or Problem · 1
A MEDTRONIC SERVICE REP TESTED THE SYSTEM AND FOUND THAT THE NAVIGATION ACCURACY MET THE PUBLISHED SPECIFICATIONS ON THE LEFT SIDE OF THE SYSTEM. HOWEVER, THE RIGHT SIDE OF THE SYSTEM DID NOT MEET THE NAVIGATIONAL ACCURACY SPECIFICATION. THIS CAUSES THE SYSTEM INDICATED ABOVE TO BE NON-CONFORMING SINCE THE SPECIFICATIONS INDICATE THAT NAVIGATION ACCURACY IS WITHIN PUBLISHED SPECIFICATIONS FOR BOTH SIDES OF THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | O-ARM 1000 IMAGING SYSTEM | MOBILE X-RAY SYSTEM (IZL) | IZL | MEDTRONIC NAVIGATION | BI-700-00027-120 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NONE | MEDTRONIC STEALTHSTATION |