FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD
MDR report key: 23439379
·
Received October 31, 2025
Report
- Report Number
- 3003768277-2025-013687
- Event Type
- Malfunction
- Date Received
- October 31, 2025
- Date of Event
- October 25, 2021
- Report Date
- October 31, 2025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- UDI-DI
- 00884838059054
- PMA / PMN Number
- K130638
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PHILIPS SERVICE REPLACED THE 19" COLOR LCD MONITOR ER (DC19-LER) AND RESTORED THE DEVICE. 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 THE CENTER MONITOR ON MCS WAS BLANK, AND DIAGNOSTICS CONFIRMED A DEFECTIVE MONITOR ON AN 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 |
|---|---|---|---|---|---|---|---|
| 1385533 | ALLURA XPER FD | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | ALLURA XPER FD20 | 00884838059054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |