AZURION 3 M15

Additional Manufacturer Narrative

PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS FIELD SERVICE ENGINEER INSPECTED THE AZURION SYSTEM ON SITE AND CONFIRMED, THAT THERE WAS NO MALFUNCTION. BUT DETERMINED, THAT THE UNINTERRUPTIBLE POWER SUPPLY (UPS) MANUFACTURED BY VERTIV, WHICH WAS CONNECTED TO THE AZURION SYSTEM, WAS NOT FUNCTIONING PROPERLY. A VERTIV REPRESENTATIVE WAS DISPATCHED, WHO RECALIBRATED THE UPS. BASED ON THE INFORMATION COLLECTED AND INVESTIGATION PERFORMED, PHILIPS CANNOT CONFIRM IF THE REPORTED PROBLEM HAD ANY CONTRIBUTION TO THE OUTCOME OF THE PATIENT. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

Additional Manufacturer Narrative

WHEN THE INVESTIGATION HAS BEEN COMPLETED PHILIPS WILL INFORM THE FDA.

Description of Event or Problem

IT WAS REPORTED TO PHILIPS THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE AZURION SYSTEM SHUT DOWN BECAUSE OF LOSS OF POWER. THE INVOLVED PATIENT PASSED AWAY. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.