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

Model Number 722026

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to philips that a patient with cardiac symptoms was transferred urgently from the emergency department to the cardiac catheterization laboratory for coronary angiography.At the start of the procedure it was discovered that the cine application was not available.Manufacturer was contacted for technical support.This did not solve the problem.The customer decided to transfer the patient to another room with a fluoroscopic x¿ray system.There were no complications or harm that resulted to the patient because of the immediate availability of another room.Customer has reported this to the fda (medwatch (b)(4)).

Manufacturer Narrative

Philips investigated this complaint.Analysis of the log-file showed that the image processing pc (ippc) had startup problems and booted up slowly.Fluoroscopy was available but exposure (¿cine application¿) was not possible.Issue was solved by rebooting the system.No negative trend has been identified with the ippc´s.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 7406351
• MDR Text Key: 105318135
• Report Number: 3003768277-2018-00026
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838054189
• UDI-Public: (01)00884838054189
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 44 YR