MAUDE Adverse Event Report: PHILIPS HEALTHCARE INTEGRIS ALLURA 9; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 722018

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

Patient Problem Hair Loss (1877)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Philips was informed that a patient suffered from alopecia after an embolization procedure which took approximately 57 minutes.

Manufacturer Narrative

Philips investigated this complaint.Philips checked the system and analyzed the system log files.No system malfunction was identified.The system was working within specification.According to the information gathered during the investigation, the patient underwent 3 procedures in 2 days.The total dose received could have resulted in the reported hair loss (628 mgycm during a ct scan, 693 mgy during the angiography diagnostic and 4006 mgy during the angiography procedure).The hair loss of the patient is temporary, therefore the type of this report has been changed to non-adverse event.No further actions will be taken by philips.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.

Manufacturer Narrative

The hair loss of the patient is temporary, therefore the type of this report has been changed to non-adverse event.No system malfunction was identified.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: INTEGRIS ALLURA 9
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 8216880
• MDR Text Key: 132058132
• Report Number: 3003768277-2019-00002
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K002016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2019

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: 722018
• Device Catalogue Number: 722018
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 01/03/2019; 01/03/2019
• Supplement Dates FDA Received: 04/23/2019; 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 78