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

Model Number AZURION 7 M20

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 09/20/2023

Event Type  Injury  

Event Description

It was reported to philips that a patient received a laceration from the edge of a rail while getting on the table of an azurion 7 m20.Bleeding from the laceration was evident and the patient required stitches.The system was in clinical use at the time of the event.Philips has started an investigation regarding the reported issue.

Manufacturer Narrative

Philips has concluded the investigation of this reported issue.According to the information obtained from the customer, prior to a diagnostic procedure, while transferring the patient on to the table the patient sustained an injury on her lower leg.The transfer was performed with the assistance of three staff members and the utilization of a stepper to properly position the patient on to the table.It was reported that the injury was due to contact of the patient¿s lower leg with the table rail area.The injury was described as a laceration on the lower leg which required an unknown number of stitches to the affected area.No additional clinical information will be forthcoming per the customer contact.It was confirmed by the customer that the table brakes were applied during the transfer.A philips field service engineer inspected the system onsite and confirmed that there were no issues with the table cover.Additionally, the visual inspection confirmed that the table's edges and corners were intact and properly positioned.The hooked edge of the rail that came in contact with the patient¿s lower leg is located below the table cover.The hooked edge is intended to prevent fluid ingress below the table.The edges and corners of the table are not positioned within the regular path of a patient transfer.No similar events have been reported to philips per the date of this report.The codes were updated based on the investigation outcome.

• 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: 17835608
• MDR Text Key: 324498656
• Report Number: 3003768277-2023-05363
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838099258
• UDI-Public: 00884838099258
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K200917
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AZURION 7 M20
• Device Catalogue Number: 722224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2022
• 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
• Patient Age: 89 YR
• Patient Sex: Female