FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD
MDR report key: 23423371
·
Received October 30, 2025
Report
- Report Number
- 3003768277-2025-013453
- Event Type
- Malfunction
- Date Received
- October 30, 2025
- Date of Event
- September 29, 2021
- Report Date
- October 30, 2025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- UDI-DI
- 00884838054189
- PMA / PMN Number
- K162859
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PHILIPS SERVICE TESTED THE SYSTEM, CREATED BACKUPS, AND RETURNED THE DEVICE 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 PATIENT DATA RETRIEVAL FAILED INTERMITTENTLY ON ISW ON AN ALLURA XPER FD10. 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 |
|---|---|---|---|---|---|---|---|
| 1541296 | ALLURA XPER FD | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | ALLURA XPER FD10 | 00884838054189 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |