FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD
MDR report key: 15963339
·
Received December 12, 2022
Report
- Report Number
- 3003768277-2022-01477
- Event Type
- Malfunction
- Date Received
- December 12, 2022
- Date of Event
- November 27, 2022
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- IZI
- UDI-DI
- 00884838059047
- PMA / PMN Number
- K130842
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM WAS STOPPED AT "0:00" AND DID NOT START UP. AS PART OF THE TROUBLESHOOTING PROCESS, FSE CHECKED THE SYSTEM AND CONFIRMED THAT COMMUNICATION WITH THE UNIT (MEDIAWALL) THAT CONTROLLED THE VIDEO SIGNAL OF THE LARGE MONITOR WAS TEMPORARILY UNAVAILABLE. FSE REPLACED RGB MEDIAWALL. AFTER REPLACEMENT OF THE RGB MEDIAWALL, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.
Description of Event or Problem · 0
IT HAS BEEN REPORTED TO PHILIPS THAT SYSTEM STOPPED AT "0:00" AND SYSTEM DID NOT START UP. THE SYSTEM WAS NOT IN CLINICAL USE. THERE WAS NO REPORTED PATIENT OR USER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2146435 | ALLURA XPER FD | SYSTEM, X-RAY, ANGIOGRAPHIC | IZI | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | ALLURA XPER FD10/10 | 00884838059047 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |