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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number AZURION 7 M20
Device Problem Insufficient Information (3190)
Patient Problem Bone Fracture(s) (1870)
Event Date 01/29/2024
Event Type  Injury  
Event Description
It has been reported to philips that a nurse sustained a fracture on the tip of a finger (distal) when she placed her hand under the azurion table while it was in motion.Her finger was immobilized with a splint.The device was not in clinical use at the time of the reported event.There was no allegation of system malfunction, however a request to check the table for possible improvements was received.Philips has started an investigation of this complaint.
 
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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
derrick massuri
3000 minuteman rd
andover, MA 01810
6172455900
MDR Report Key18668044
MDR Text Key334902285
Report Number3003768277-2024-00753
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K172822
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
1 Device was Involved in the Event
Date FDA Received02/08/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberAZURION 7 M20
Device Catalogue Number722079
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/29/2024
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
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