MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722026

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem Cardiac Arrest (1762)

Event Date 11/08/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to philips that during the preparation of a stemi case the system froze and took longer than expected to reboot.During this time the patient suffered a cardiac arrest and was resuscitated.After this, the revascularization procedure was completed successfully.The patient remained intubated and was subsequently transferred to another facility.The patient¿s current status is not known.

Manufacturer Narrative

Philips investigated this complaint.The system software froze when the patient was being prepared for the procedure.Several attempts were required to reboot the system contributing to a total delay in performing the procedure of approximately 30 minutes.Philips checked the system on site and confirmed that the host pc was not operating correctly.The host pc was replaced after which the system was returned to use in good working order.An analysis of the log files confirmed a failure of the host pc.Further investigation of the nature of the failure was not possible because customer had destroyed the hard disk containing necessary dump files.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: ALLURA XPER FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 8136989
• MDR Text Key: 129493483
• Report Number: 3003768277-2018-00092
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K031333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 722026
• Device Catalogue Number: 722026
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 11/08/2018
• Supplement Dates FDA Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening