FDA Adverse Event
Malfunction
Summary report: N
AZURION
MDR report key: 21281620
·
Received January 31, 2025
Report
- Report Number
- 3003768277-2025-000883
- Event Type
- Malfunction
- Date Received
- January 31, 2025
- Date of Event
- May 30, 2022
- Report Date
- January 31, 2025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- UDI-DI
- 00884838085251
- PMA / PMN Number
- K172822
- Removal / Correction Number
- C&R#: 3003768277-12/08/2
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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#: 3003768277-12/08/2023-009-C.
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT SYSTEM CRASHES SPORADICALLY BY ITSELF, NO OPERATION POSSIBLE. THIS IS CONNECTED TO A LOSS OF IMAGE RELATED TO A AZURION 7 M12. THERE WAS NO REPORTED PATIENT OR USER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2150913 | AZURION | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | AZURION 7 M12 | 00884838085251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |