MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20; ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER

Model Number 722006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hair Loss (1877)

Event Date 03/25/2015

Event Type  Injury  

Event Description

The customer reported to philips that they had a patient with hairloss symptoms after interventional neuro operation.

Manufacturer Narrative

When investigation is completed, a follow up report will be sent to fda.

Manufacturer Narrative

Philips visited the customer and did an inspection of the system , the field service engineer performed some image quality and radiation tests, and found the system is working as intended.An application specialist was involved to observe the customers' way of working and noticed the user was always selecting 6 frames per second.Philips suggested the customer to reduce the framerate from 6 frames per second to 3 frames per second.The application specialist changed the exposure protocol for neuro operations to 2fps (half of the original), the default fluoro flavor is set to low for neuro operations and the detector dose changed from 6 frames per second to 3 frames per second.With this change the customer is still satisfied about the image quality.The application specialist also gave the customer a training on the system.Since the doctor started working with 3 fps or less there were no new patients with hair loss reported to philips.(b)(4) contact office address: (b)(4).

Event Description

The customer reported to philips that they had a patient with hairloss symptoms after interventional neuro operation.

• Brand Name: ALLURA XPER FD20
• Type of Device: ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 4745832
• MDR Text Key: 5883770
• Report Number: 3003768277-2015-00036
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/07/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: 722006
• Device Catalogue Number: 722006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 05/04/2015
• 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 Outcome(s): Other