MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number AZURION 7 B20

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

Patient Problem Hair Loss (1877)

Event Date 04/04/2023

Event Type  Injury  

Event Description

It has been reported to philips that a patient experienced hair loss on the head after having a procedure on the azurion system.The issue also occurred with another patient which has been reported via philips reference (b)(4) a philips engineer inspected the system onsite and performed system tests.The system dose levels were according to specification and no malfunction of the system was identified.We are conservatively reporting this event as the investigation is ongoing.A follow up report will be submitted when further information is received.

Manufacturer Narrative

It was identified that this is a duplicate complaint from an already reported complaint.The investigation will be addressed in mfr report number 3003768277-2023-02314.This complaint will be closed as duplicate.

• Brand Name: AZURION
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16743097
• MDR Text Key: 313324287
• Report Number: 3003768277-2023-02309
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085367
• UDI-Public: 00884838085367
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K163715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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: AZURION 7 B20
• Device Catalogue Number: 722068
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/19/2023
• 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