FDA Adverse Event
Malfunction
Summary report: N
NL5000
MDR report key: 19355093
·
Received May 20, 2024
Report
- Report Number
- 3004938766-2024-00018
- Event Type
- Malfunction
- Date Received
- May 20, 2024
- Date of Event
- April 12, 2024
- Report Date
- May 15, 2024
- Manufacturer
- NEUROLOGICA CORPORATION
- Product Code
- JAK
- PMA / PMN Number
- K202526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER SCANNER, CAUSING A DELAY IN TREATMENT. WE HAVE IMPLEMENTED CORRECTIVE MEASURES TO MITIGATE THE RISK AND PREVENT ERRORS THROUGH SERVICE VISITS. DAILY CALIBRATION AND QUALITY ASSURANCE TESTING WERE COMPLETED ON THE SYSTEM WITH NO ISSUES. ANY ADDITIONAL INFORMATION RECEIVED ON THIS INCIDENT WILL BE REPORTED IN A FOLLOW-UP MDR.
Description of Event or Problem · 0
THERE WAS A MALFUNCTION WITH THE SCANNER, WHICH CAUSED A DELAY IN THE PATIENT'S TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1767998 | NL5000 | COMPUTED TOMOGRAPHY X-RAY SYSTEM | JAK | NEUROLOGICA CORPORATION | NL5000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |