FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD
MDR report key: 11698981
·
Received April 21, 2021
Report
- Report Number
- 3003768277-2021-10011
- Event Type
- Malfunction
- Date Received
- April 21, 2021
- Date of Event
- March 31, 2021
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OWB
- UDI-DI
- 00884838059054
- PMA / PMN Number
- K130638
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS ENGINEER CHECKED THE SYSTEM ONSITE AND IDENTIFIED THAT THE HOST PC FAILED. THE HOST PC WAS REPLACED AFTER WHICH THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.
Description of Event or Problem · 1
IT HAS BEEN REPORTED TO PHILIPS THAT WHEN STARTING UP THE SYSTEM FOR A STROKE EMERGENCY PROCEDURE, THE SYSTEM COULD NOT BOOT UP PROPERLY. THE PROCEDURE WAS COMPLETED ON ANOTHER SYSTEM. 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 |
|---|---|---|---|---|---|---|---|
| 600399 | ALLURA XPER FD | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | ALLURA XPER FD20 | 00884838059054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |