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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER
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PHILIPS HEALTHCARE ALLURA XPER FD10; ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER Back to Search Results
Model Number 722026
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Philips received a complaint from a customer that the system failed during transcatheter aortic valve implantation (tavi) procedure on a patient.The system failed just as they were about to deploy the valve.The particular component that has failed was the flexvision pc.Backup measures in place helped prevent any serious injury.
 
Manufacturer Narrative
(b)(4).When investigation is complete a follow up report will be sent to fda.
 
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Brand Name
ALLURA XPER FD10
Type of Device
ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER
Manufacturer (Section D)
PHILIPS HEALTHCARE
veenpluis 4-6
best 5680
NL  5680
Manufacturer Contact
deborah thurston
3000 minuteman rd.
andover, MA 01810
9786592010
MDR Report Key4363761
MDR Text Key19349893
Report Number3003768277-2014-00135
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K041949
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number722026
Device Catalogue Number722026
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/22/2014
Initial Date FDA Received12/18/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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