MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILLIPS IGT ALLURA FD ESSENTIALS 28; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number ALLURA FD ESSENTIALS 28

Device Problems Device Alarm System (1012); Computer Software Problem (1112)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2018

Event Type  malfunction  

Event Description

This is just a comment about the design of the product.Re: phillips igt allura fd essentials 28 imaging equipment for cath lab.The imaging equipment takes a picture and then stores the picture on the internal hard drive.The system does not inform you when the hard drive is full.So, the hard drive could be full and you could still be taking pictures thinking that the pictures are being saved onto the drive.However, they are not being saved onto the drive once the drive is full.If you try to retrieve them, they won't be there.By comparison, another manufacturer's equipment will tell you when the hard drive is full, so that you can delete older images and free up space on the drive to store new images.

• Brand Name: PHILLIPS IGT ALLURA FD ESSENTIALS 28
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 595 miner road; cleveland OH 44143
• MDR Report Key: 7663340
• MDR Text Key: 113190786
• Report Number: 7663340
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA FD ESSENTIALS 28
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1