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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 Unintended System Motion (1430)
Patient Problem Pneumothorax (2012)
Event Date 09/07/2023
Event Type  Injury  
Event Description
It was reported to philips that when preparing for a cone-beam computed tomography (cbct), the technologist selected the cbct function and then accidentally pressed the ¿reset geo¿ button instead of the ¿accept¿ button.Pressing the ¿reset geo¿ button reset the device¿s stand and table position which made the table raise and move laterally, causing an endotracheal (et) tube and catheter to move within the patient¿s lung.The patient was diagnosed with a pneumothorax at the end of the case, which required a chest tube be placed and the patient stay overnight in the hospital.The physician stated they believed the movement of the table could have caused the pneumothorax.The patient¿s status was reported as recovered.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 Key17994297
MDR Text Key326355401
Report Number3003768277-2023-05775
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00884838099258
UDI-Public00884838099258
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200917
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number722224
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/25/2023
Initial Date FDA Received10/24/2023
Date Device Manufactured02/01/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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