ALLURA XPER FD20/10 & ALLURA XPER FD20/20
Report
- Report Number
- 3003768277-2025-005194
- Event Type
- Malfunction
- Date Received
- June 9, 2025
- Date of Event
- June 2, 2025
- Report Date
- July 31, 2025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- PMA / PMN Number
- K033737
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE ISSUE OCCURRED DURING A CORONARY PROCEDURE AND THE PROCEDURE WAS COMPLETED USING A MOBILE C-ARM. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM WAS UNABLE TO PRODUCE X-RAYS. UPON ANALYSIS, THE FSE REVIEWED THE LOGFILE WHICH INDICATED AN ISSUE WITH THE FLAT DETECTOR CONTROL (FDC) BOARD ON THE FRONTAL STAND. THE FSE SWAPPED THE LATERAL AND FRONTAL FDC BOARDS AS A TEMPORARY SOLUTION BUT AFTER THAT THE LATERAL FDC BOARDS SHOWED INTERMITTENT ISSUES. THE FSE CONFIRMED THAT THE FDC BOARD WAS DEFECTIVE AND NEEDED A REPLACEMENT. TO RESOLVE THE REPORTED ISSUE, THE FSE REPLACED THE FDC BOARD. AFTER REPLACEMENT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. HEALTH IMPACT CODE WAS CORRECTED.
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PRODUCE X-RAYS. THE SYSTEM WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1477980 | ALLURA XPER FD20/10 & ALLURA XPER FD20/20 | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | ALLURA XPER FD20/10 & FD20/20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |