FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD20
MDR report key: 22991386
·
Received September 8, 2025
Report
- Report Number
- 3003768277-2025-009254
- Event Type
- Malfunction
- Date Received
- September 8, 2025
- Date of Event
- May 23, 2022
- Report Date
- September 8, 2025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- PMA / PMN Number
- K033737
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PHILIPS SERVICE REPLACED THE DEFECTIVE 19" COLOR LCD MONITOR ER (DC19-LER) AND TESTED THE SYSTEM FUNCTIONALITY, RETURNING IT TO USE. THIS REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE: (B)(4)).
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT A BAD MONOCHROME MONITOR IN THE EXAM ROOM CAUSED NO IMAGE DISPLAY ON A ALLURA XPER FD20. THE CLINICAL USE OF THE SYSTEM WAS IN USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2495973 | ALLURA XPER FD20 | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | ALLURA XPER FD20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |