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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER WITH FLEXVISION; SYSTEM, X-RAY, ANGIOGRAPHIC
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PHILIPS HEALTHCARE ALLURA XPER WITH FLEXVISION; SYSTEM, X-RAY, ANGIOGRAPHIC Back to Search Results
Device Problems No Display/Image (1183); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/19/2019
Event Type  malfunction  
Event Description
This patient was on cath lab table, and as we were about to start the procedure, x-ray didn't work.A soft and a hard reboot was done without any improvement.Phillips will be called for notification.Patient was transferred to another lab to perform the case.Replaced the dcps power supply in the b-cabinet - rechecked everything and system was stable.Philips service report: flexvision monitor went dark.The fd system, the x-ray generator, and all of the monitors in the control room remained operational.What actions were taken to repair the equipment? replaced the dcps power supply in the b-cabinet.The customer was advised that if the problem happens again, to please note the color of the led in the bottom right corner of the flexvision to help with diagnostics.Tested the system and the system checked ok.
 
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Brand Name
ALLURA XPER WITH FLEXVISION
Type of Device
SYSTEM, X-RAY, ANGIOGRAPHIC
Manufacturer (Section D)
PHILIPS HEALTHCARE
3721 valley centre drive, suite 500
san diego CA 92130
MDR Report Key10009002
MDR Text Key189322711
Report Number10009002
Device Sequence Number1
Product Code IZI
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 04/21/2020
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 Other
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/21/2020
Event Location Hospital
Date Report to Manufacturer04/29/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/29/2020
Type of Device Usage N
Patient Sequence Number1
Patient Age22265 DA
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