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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 Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2023
Event Type  malfunction  
Event Description
It has been reported to philips that there were intermittent shutter errors.The issue was found during clinical use.No harm has been reported to philips.Philips has started an investigation of this complaint.
 
Manufacturer Narrative
Philips has investigated this complaint.The philips remote service engineer (rse) inspected the system remotely, did functional analysis and confirmed that there were intermittent collimator shutter errors.Review of the system log file showed that there were issues with collimator hardware.The fse did the troubleshooting actions and found that the power supply was damaged.The fse resolved the issue by testing and checking the connections.After this, the system was returned to use in good working order.The codes were updated based on the investigation outcome.Evaluation method code was corrected.
 
Manufacturer Narrative
Philips has investigated this complaint.The philips remote service engineer (rse) inspected the system remotely, did functional analysis and confirmed that there were intermittent collimator shutter errors.Review of the system log file showed that there were issues with collimator hardware.The rse did the troubleshooting actions and found that the power supply was damaged.The rse resolved the issue by testing and checking the connections.After this, the system was returned to use in good working order.Evaluation method code was corrected.
 
Event Description
It has been reported to philips that there were intermittent shutter errors.The issue was found during clinical use.No harm has been reported to philips.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
dusty leppert
3000 minuteman rd
andover, MA 01810
6172455900
MDR Report Key17163615
MDR Text Key317494902
Report Number3003768277-2023-03736
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00884838085268
UDI-Public00884838085268
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163715
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAZURION 7 M20
Device Catalogue Number722079
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received09/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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