MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH AZURION 3 M15; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722064

Device Problems Loss of Power (1475); Unexpected Shutdown (4019)

Patient Problem Death (1802)

Event Date 08/08/2020

Event Type  Death  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

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.

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.

• Brand Name: AZURION 3 M15
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstr. 24; hamburg 22335 ; GM 22335
• MDR Report Key: 10430758
• MDR Text Key: 203656789
• Report Number: 3003768251-2020-00004
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085282
• UDI-Public: (01)00884838085282
• Combination Product (y/n): N
• PMA/PMN Number: K172822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722064
• Device Catalogue Number: 722064
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Weight: 70