FDA Adverse Event
Malfunction
Summary report: N
O-ARM 1000 IMAGING SYSTEM
MDR report key: 3874314
·
Received June 16, 2014
Report
- Report Number
- 1723170-2014-00463
- Event Type
- Malfunction
- Date Received
- June 16, 2014
- Date of Event
- January 16, 2014
- Report Date
- January 16, 2014
- Manufacturer
- MEDTRONIC NAVIGATION, INC. (LITTLETON)
- Product Code
- OXO
- PMA / PMN Number
- K050996
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. REPLACEMENT DEVICE SHIPPED TO SITE (B)(4) 2014. A MEDTRONIC REPRESENTATIVE REPORTED THAT THERE WERE BATTERIES THAT WERE SHORTED AND MELTED TOGETHER. (B)(4) - A MEDTRONIC REPRESENTATIVE REPLACED THE BATTERIES AND PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. MOST LIKELY ROOT CAUSE ARE THE BATTERIES. BATTERIES WERE NOT RETURNED TO MANUFACTURER FOR ANALYSIS.
Description of Event or Problem · 1
A SITE BIOMED REPRESENTATIVE REPORTED A BURNING SMELL COMING FROM THE O-ARM 1000 IMAGING SYSTEM. THE SYSTEM WAS SHUT OFF AND NOT IN USE BUT WAS PLUGGED INTO THE WALL AND CHARGING WHEN THIS WAS NOTED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352201 | O-ARM 1000 IMAGING SYSTEM | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE | OXO | MEDTRONIC NAVIGATION, INC. (LITTLETON) | BI-700-00027-120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |