FDA Adverse Event
Malfunction
Summary report: N
OXO -IMAGE-INTENSIFIED
MDR report key: 10162850
·
Received June 17, 2020
Report
- Report Number
- 3004785967-2020-00699
- Event Type
- Malfunction
- Date Received
- June 17, 2020
- Date of Event
- June 12, 2020
- Report Date
- June 17, 2020
- Manufacturer
- MEDTRONIC NAVIGATION, INC (LITTLETON)
- Product Code
- OXO
- UDI-DI
- 00643169353428
- PMA / PMN Number
- K151000
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THERE WAS BENT PIN ON BACKPLANE. THEY STRAIGHTEN PIN ON THE CANNON CONNECTION PORT. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEMS O-ARM WAS UNABLE TO RECEIVE POWER. IT WAS NOTED THAT THEY WERE UNABLE TO CONNECT THE UMBILICAL CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 625942 | OXO -IMAGE-INTENSIFIED | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE | OXO | MEDTRONIC NAVIGATION, INC (LITTLETON) | BI70000028120 | 00643169353428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |