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

Model Number AZURION 7 M12

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Insufficient Information (4580)

Event Date 02/14/2022

Event Type  Injury  

Event Description

It has been reported to philips that the l-arm rotation cover fell down following a collision with the radiation shield.The cover was not retained by the safety chain and fell on the patient.The patient¿s face and chest were injured, resulting in a bloody face; however, it is unknown the extent of the injury or if additional intervention was required to treat the patient.Philips has attempted to obtain further information on reported incident and the patient outcome.Philips has started an investigation of this complaint.Based on the information received, this event is being conservatively reported at this time.

Manufacturer Narrative

Additional narrative: philips has investigated this complaint.According to the addition information collected, the patient sustained cuts in the face which were covered with band-aid.No further treatment was required.The procedure was completed successfully.The clip that retains the chain to the cover bent open.As a result, the cover detached and fell on the patient after colliding with the radiation shield.A new l-arm cover was supplied to the customer.The customer replaced the l-arm cover and the system was back to use in good working order.Philips has completed a good faith effort to collect patient information.However, the customer has not provided the requested information.Corrected data: codes have been updated h3 other text : remote support delivered to customer.

• Brand Name: AZURION
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13635816
• MDR Text Key: 286346684
• Report Number: 3003768277-2022-00084
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085251
• UDI-Public: 00884838085251
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K172822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AZURION 7 M12
• Device Catalogue Number: 722078
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2018
• 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