FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD
MDR report key: 23037078
·
Received September 12, 2025
Report
- Report Number
- 3003768277-2025-010001
- Event Type
- Malfunction
- Date Received
- September 12, 2025
- Date of Event
- July 20, 2022
- Report Date
- September 12, 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
A WORKAROUND SOLUTION WAS PROVIDED TO THE CUSTOMER. THIS REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE: GEN2400312).
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM BOOTING TIMED OUT AT ZERO DURING DIAGNOSTIC USE 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 |
|---|---|---|---|---|---|---|---|
| 2705828 | 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 |