FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD20
MDR report key: 22961626
·
Received September 4, 2025
Report
- Report Number
- 3003768277-2025-008936
- Event Type
- Malfunction
- Date Received
- September 4, 2025
- Date of Event
- June 23, 2021
- Report Date
- September 4, 2025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- PMA / PMN Number
- K033737
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PHILIPS SERVICE REPLACED THE 19'' MONOCHROME MONITOR ER (MML1952-PER) AND 19" COLOR LCD MONITOR ER (DC19-LER) AND PROVIDED A COMPUTER REPLACEMENT QUOTE. 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 BOOM MONITORS WERE DEFECTIVE, AND THE INTERVENTIONAL TOOLS COMPUTER CRASHED 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 |
|---|---|---|---|---|---|---|---|
| 1472899 | ALLURA XPER FD20 | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | ALLURA XPER FD20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |