FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD
MDR report key: 22905025
·
Received August 27, 2025
Report
- Report Number
- 3003768277-2025-008261
- Event Type
- Malfunction
- Date Received
- August 27, 2025
- Date of Event
- September 13, 2021
- Report Date
- August 27, 2025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- UDI-DI
- 00884838059030
- PMA / PMN Number
- K130638
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PHILIPS SERVICE REPLACED THE NIU BOARD AND PIU BOARD, RESTORING 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 TABLE MOVEMENT WAS PARTLY AVAILABLE DUE TO SMART DRIVE FAILURE 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 |
|---|---|---|---|---|---|---|---|
| 1251354 | ALLURA XPER FD | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | ALLURA XPER FD10 | 00884838059030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |