FDA Adverse Event
Death
Summary report: N
AZURION
MDR report key: 12517751
·
Received September 23, 2021
Report
- Report Number
- 3003768277-2021-10138
- Event Type
- Death
- Date Received
- September 23, 2021
- Date of Event
- August 16, 2021
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- UDI-DI
- 00884838085251
- PMA / PMN Number
- K172822
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
IT WAS IDENTIFIED THAT THIS IS A DUPLICATE COMPLAINT FROM AN ALREADY REPORTED COMPLAINT. THE INVESTIGATION WAS ADDRESSED IN TW (B)(4). THIS COMPLAINT WILL BE CLOSED AS DUPLICATE.
Description of Event or Problem · 1
IT HAS BEEN REPORTED TO PHILIPS THAT, THE WIRELESS FOOTSWITCH FAILED TO OPERATE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING A WIRED FOOTSWITCH. NO HARM TO THE PATIENT HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1420496 | AZURION | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | AZURION 7 M12 | 00884838085251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |