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

Model Number 722001

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

Patient Problem Hair Loss (1877)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2019, it was reported to philips that a patient experienced hair loss on the back of the head 6 weeks after the procedure.The investigation is still ongoing on this event.When the investigation is completed a follow-up will sent to the fda.

Event Description

It has been reported to philips that after following a cerebrovascular procedure, a patient experienced hair loss at the back of the head.Philips has initiated an investigation of this complaint.

Manufacturer Narrative

Final philips investigated this complaint.Based on a patient¿s report of hair loss after a neuro study performed with the philips x-ray system, the customer requested philips to check the system to rule out contribution of the system.The patient in this report received a neuro examination on december 4, 2018.The procedure resulted in a total airkerma of 3124 mgy.The procedure was completed successfully.Prior to this procedure, the patient had two other neuro procedures in the same month.She reported hair loss in the back of the head six weeks after the latest procedure was performed.The customer reported hair loss to philips on february 5, 2019.Due to the time elapsed; log files from the day of the procedure are not available for analysis.Philips has inspected the system on-site and confirmed that the system is working according to specification.No malfunction of the system was identified that may have contributed to the hair loss of the patient.Philips concludes that the most likely cause of the hair loss is the high dose (3124 mgy) received by the patient in the same region of the head of the patient over multiple examinations.Consequently, philips has closed this complaint.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 C
• 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: 8390079
• MDR Text Key: 137810318
• Report Number: 3003768277-2019-00020
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 722001
• Device Catalogue Number: 722001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR