FDA Adverse Event
Malfunction
Summary report: N
O-ARM
MDR report key: 8716602
·
Received June 20, 2019
Report
- Report Number
- 3004785967-2019-01103
- Event Type
- Malfunction
- Date Received
- June 20, 2019
- Date of Event
- June 3, 2019
- Report Date
- June 20, 2019
- Manufacturer
- MEDTRONIC NAVIGATION, INC (LITTLETON)
- Product Code
- OXO
- PMA / PMN Number
- K050996
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. CONCOMITANT MEDICAL PRODUCT: OTHER RELEVANT DEVICE(S) ARE. FOREIGN COUNTRY: (B)(6). THE MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE IMAGING SYSTEM. THE REPORTED ISSUE WAS CONFIRMED AND PARTS WERE REPLACED. THE MANUFACTURE DATE WAS UNAVAILABLE AT THE TIME OF REPORTING. 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. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THERE WAS AN ERROR MESSAGE THAT STATED "MVW PICTURES TRANSFER RATE IS TOO LOW CHECK CONNECTION BETWEEN IMAGING SYSTEM AND MOBILE VIEW STATION (MVS)". NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509501 | O-ARM | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE | OXO | MEDTRONIC NAVIGATION, INC (LITTLETON) | BI70000028230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |