FDA Adverse Event
Summary report: N
BRILLIANCE ICT
MDR report key: 3760728
·
Received April 9, 2014
Report
- Report Number
- 1525965-2014-00073
- Date Received
- April 9, 2014
- Report Date
- March 12, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
- Product Code
- JAK
- PMA / PMN Number
- K060937
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).
Description of Event or Problem · 1
IN THIS CASE, THE CUSTOMER REPORTED THAT THERE ARE BANDING/BUBBLE ARTIFACTS SEEN ON THE ITERATIVE MODEL RECONSTRUCTION (IMR) CARDIAC IMAGES. THE PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR, OR BYSTANDER. THE CUSTOMER STATED THAT THE BRIGHT AND DARK BANDS COULD BE INTERPRETED AS LOW DENSITY CALCIUM AND COULD BE MISTAKEN FOR DISEASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213275 | BRILLIANCE ICT | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | JAK | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | 728306 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |