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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 B20
Device Problems Device Displays Incorrect Message (2591); Radiation Output Failure (4027)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/21/2022
Event Type  malfunction  
Event Description
Grid voltage error - tube related.Please look into logfiles.It has been reported to philips that the lateral x-ray tube is defective.The device was in clinical use.Philips has started an investigation of the complaint.
 
Manufacturer Narrative
Philips has investigated this complaint.The philips field service engineer (fse) inspected the system onsite and confirmed that there was a grid voltage error which was due to the x-ray generator or x-ray tube hardware.Review of the system log file showed a grid leak error resulted in the restarting of the generator.After the generator restart x-ray was still available without the grid.The fse resolved the grid switch problem onsite and the system was returned to use in good working order.At the time this complaint was received, philips did not have enough information to exclude the potential for death or serious injury on recurrence, and as such the complaint was reported.X-ray could still be performed, therefore, the unavailability of the grid is not likely to cause or contribute to a serious injury or death.Based on the new information, this complaint is evaluated as not reportable.The codes were updated based on the investigation outcome.Evaluation method code was corrected.
 
Event Description
Grid voltage error - tube related.Please look into logfiles.It has been reported to philips that the lateral x-ray tube is defective.The device was in clinical use.Philips has started an investigation of the complaint.
 
Manufacturer Narrative
Philips has investigated this complaint.According to the additional information acquired, the system displayed an error message alerting the user that the tube grid was defective.Log file analysis found that there was no actual grid switch failure, confirming that the error message was a false alarm.No malfunction of the system tube was identified.A philips field service engineer inspected the system on site and performed a service procedure to resolve the grid switch user messages.After performing functional tests, the system was returned to use in good working order.At the time this complaint was received, philips did not have enough information to exclude the potential for death or serious injury on recurrence, and as such the complaint was reported.Log file analysis confirmed that there was no actual grid switch malfunction.Based on the investigation results, philips concluded that the complaint is not reportable.The codes were updated based on the investigation outcome.Device problem code and evaluation method code were corrected.
 
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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 Key15909575
MDR Text Key305385397
Report Number3003768277-2022-01336
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00884838085367
UDI-Public00884838085367
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K172822
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAZURION 7 B20
Device Catalogue Number722068
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/28/2023
Was Device Evaluated by Manufacturer? Yes
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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