FDA Adverse Event
Malfunction
Summary report: N
OMNITOM
MDR report key: 10216322
·
Received July 1, 2020
Report
- Report Number
- 3004938766-2020-00007
- Event Type
- Malfunction
- Date Received
- July 1, 2020
- Date of Event
- February 24, 2020
- Report Date
- June 30, 2020
- Manufacturer
- NEUROLOGICA CORPORATION
- Product Code
- JAK
- PMA / PMN Number
- K171183
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE EVENT WAS REPORTED TO THE FDA ((B)(4)) BY THE USER FACILITY TO THE FDA AND THE MANUFACTURER IS REPORTING THIS MDR WITH ADDITIONAL CONTEXT. THERE WAS NO INJURY ASSOCIATED WITH THIS ISSUE. UPON ROOT CAUSE ANALYSIS BY OUR SERVICE TECHNICIAN, IT WAS FOUND THAT A WIRE HAD COME OFF. THE SERVICE ENGINEER REPLACED THE ELECTRICAL COMPONENTS AND THE CT SYSTEM IS BACK UP AND FULLY OPERATIONAL. THE CT SYSTEM PASSED THE DAILY CALIBRATION AND QA CHECK.
Description of Event or Problem · 1
THE OMNITOM COMPUTED TOMOGRAPHY (CT) SYSTEM DID NOT POWER UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 682901 | OMNITOM | COMPUTED TOMOGRAPHY X-RAY SYSTEM | JAK | NEUROLOGICA CORPORATION | NL5000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |