FDA Adverse Event
Injury
Summary report: N
ALLURA XPER FD
MDR report key: 14733285
·
Received June 17, 2022
Report
- Report Number
- 3003768277-2022-00287
- Event Type
- Injury
- Date Received
- June 17, 2022
- Date of Event
- April 11, 2022
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- UDI-DI
- 00884838059030
- PMA / PMN Number
- K130638
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
A PHILIPS SERVICE ENGINEER INSPECTED THE SYSTEM ONSITE AND IDENTIFIED A PROBLEM WITH THE HOST PC. THE HOST PC WAS REPLACED AND THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.
Description of Event or Problem · 0
IT HAS BEEN REPORTED TO PHILIPS THAT DURING A PACEMAKER IMPLEMENTATION PROCEDURE, THE ALLURA SYSTEM BECAME UNAVAILABLE (IMAGE FROZEN) AND X-RAY WAS NOT POSSIBLE. A REBOOT OF THE SYSTEM WAS UNSUCCESSFUL IN BRINGING THE SYSTEM BACK TO FUNCTIONAL STATE. THE CUSTOMER REPORTED THE PACEMAKER PROBE HAD BEEN ADVANCED INTO THE RIGHT ATRIUM WHEN THE SYSTEM BECAME UNAVAILABLE. THE PROCEDURE WAS ABORTED AT THIS TIME AND THE CHEST INCISION WAS SURGICALLY CLOSED. THE PROCEDURE WAS RESCHEDULED AND THE PATIENT WAS RETURNED TO THE WARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1398783 | ALLURA XPER FD | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | ALLURA XPER FD10 | 00884838059030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |