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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; SYSTEM, X-RAY, ANGIOGRAPHIC
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; SYSTEM, X-RAY, ANGIOGRAPHIC Back to Search Results
Model Number ALLURA XPER FD20
Device Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2024
Event Type  malfunction  
Event Description
It has been reported to philips that the auxiliary monitors in the room and the flexvision monitors had color bars.The customer could not see any live or reference images.The system was in clinical use and the procedure was cancelled.There was no reported patient or user harm.A philips field service engineer (fse) replaced the dvi matrix switch and the flexvision pc which returned the system to use in good working order.
 
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Brand Name
ALLURA XPER FD
Type of Device
SYSTEM, X-RAY, ANGIOGRAPHIC
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
derrick massuri
3000 minuteman rd
andover, MA 01810
6172455900
MDR Report Key19212935
MDR Text Key341385644
Report Number3003768277-2024-02521
Device Sequence Number1
Product Code IZI
UDI-Device Identifier00884838059054
UDI-Public00884838059054
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
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 NumberALLURA XPER FD20
Device Catalogue Number722012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/09/2024
Initial Date FDA Received04/30/2024
Date Device Manufactured11/07/2012
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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