FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD
MDR report key: 22083682
·
Received May 26, 2025
Report
- Report Number
- 3003768277-2025-004737
- Event Type
- Malfunction
- Date Received
- May 26, 2025
- Date of Event
- July 6, 2022
- Report Date
- May 26, 2025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- UDI-DI
- 00884838059054
- PMA / PMN Number
- K130638
- Removal / Correction Number
- C&R#: 3003768277-12/28/
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE: (B)(4) AND IS RELATED TO AND OCCURRED PRIOR TO (C&R#: 3003768277-12/28/2023-012-C).
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT STARTUP FAULT. THIS IS CONNECTED TO STARTUP ISSUES RELATED TO A ALLURA XPER FD20. THERE WAS NO REPORTED PATIENT OR USER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331833 | 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 |