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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
Device Problem Operating System Becomes Nonfunctional (2996)
Patient Problem Insufficient Information (4580)
Event Date 03/15/2023
Event Type  malfunction  
Event Description
Clarity info: x-ray tube system was turned on, as routinely done in the a.M.After being shut down the night before.After system was on, table was moveable and was ready for use.Patient (pt) was brought into procedure room, sedated and intubated.Access to sites was obtained.Dr.Advanced the ultrasound catheter into the heart.Heparin had been given.When going to take x-ray image, system was not functioning.No error codes displaying to the team.Biomed was called.Decision to abort procedure, as system not operational and maintenance personnel coming from 1 hour away.Heparin being reversed, pt will be extubated and will recover in pacu (post-anesthesia care unit).See biomed follow up.
 
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Brand Name
AZURION
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
222 jacobs street
cambridge MA 02141
MDR Report Key16589689
MDR Text Key311758744
Report Number16589689
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/20/2023,03/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/20/2023
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer03/22/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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