FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD
MDR report key: 22103275
·
Received May 29, 2025
Report
- Report Number
- 3003768277-2025-004866
- Event Type
- Malfunction
- Date Received
- May 29, 2025
- Date of Event
- November 19, 2021
- Report Date
- May 29, 2025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- UDI-DI
- 00884838054202
- PMA / PMN Number
- K162859
- Removal / Correction Number
- C&R#: 3003768277-06/23/2
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE: GEN2400312) AND IS RELATED TO AND OCCURRED PRIOR TO (C&R#: 3003768277-06/23/2023-004-C).
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT FOOTSWITCH OCCASIONALLY NOT CHARGING. THIS IS CONNECTED TO LOSS OF IMAGE 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 |
|---|---|---|---|---|---|---|---|
| 597601 | ALLURA XPER FD | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | ALLURA XPER FD20 | 00884838054202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |