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

Model Number AZURION 7 B20

Device Problem Entrapment of Device (1212)

Patient Problem Crushing Injury (1797)

Event Date 09/08/2021

Event Type  Injury  

Event Description

It has been reported to philips that when servicing the azurion system a philips engineer got injured.The engineer was moving the table into position when the tip of his little finger got smashed by the table bearing.The finger tip was stitched back together, the bone was crushed and will not reattach.

Manufacturer Narrative

Addtl narrative: philips investigated this complaint.While performing 3dra calibrations of the system, the engineer moved the table, grabbed the table rail and his finger got entrapped in the longitudinal guiding profiles.There was no malfunction of the system.

• 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: 12590044
• MDR Text Key: 275161202
• Report Number: 3003768277-2021-10164
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838085367
• UDI-Public: 00884838085367
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: AZURION 7 B20
• Device Catalogue Number: 722068
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2019
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 109 KG