ALLURA XPER FD
Report
- Report Number
- 3003768277-2021-10013
- Event Type
- Malfunction
- Date Received
- April 22, 2021
- Date of Event
- March 25, 2021
- Product Code
- IZI
- UDI-DI
- 00884838059054
- PMA / PMN Number
- K130842
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
CORRECTED DATA: DEVICE PROBLEM CODE HAS BEEN UPDATED FROM C62904 TO C133569 ADDTL NARRATIVE: PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED THE PROCEDURE WAS COMPLETED WITH THE ADDITIONAL SYSTEM. THE PATIENT WAS TAKEN TO THE CORONARY UNIT FOR CLOSE MEDICAL SURVEILLANCE FOR 2 DAYS. PHILIPS HAS BEEN CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT. PHILIPS INSPECTED THE SYSTEM ONSITE AND ANALYZED THE LOG FILE AND IDENTIFIED A FAILURE OF THE IMAGE PROCESSING PC. THE DEFECTIVE IMAGE PROCESSING PC WAS REPLACED, AND THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.
IT HAS BEEN REPORTED TO PHILIPS THAT DURING A CORONARY ANGIOPLASTY PROCEDURE X-RAY STOPPED WORKING, WHILE THE CATHETER WAS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A MOBILE X-RAY SYSTEM. THE PATIENT WAS MONITORED FOR 2 DAYS AT THE CORONARY UNIT. NO HARM TO THE PATIENT WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
IT HAS BEEN REPORTED TO PHILIPS THAT DURING A CORONARY ANGIOPLASTY PROCEDURE X-RAY STOPPED WORKING, WHILE THE CATHETER WAS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A MOBILE X-RAY SYSTEM. THE PATIENT WAS MONITORED FOR 2 DAYS AT THE CORONARY UNIT. NO HARM TO THE PATIENT WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 602678 | ALLURA XPER FD | SYSTEM, X-RAY, ANGIOGRAPHIC | IZI | ALLURA XPER FD20 | 00884838059054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization |