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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; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number ALLURA XPER FD10
Device Problems No Display/Image (1183); Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2023
Event Type  malfunction  
Event Description
It has been reported to philips that there was image processing failure.The system was in clinical use.No harm has been reported to philips.A philips field service engineer (fse) inspected the system onsite and confirmed that a problem with the ippc and hard disc.Philips has started an investigation of this complaint.
 
Manufacturer Narrative
Philips has investigated this complaint.According to the additional information collected, the system was in clinical use, which caused delay in diagnosis for coronary procedure.A philips field service engineer (fse) inspected the system onsite and confirmed that the image processing failure due to defective ippc disk.Fse replaced the ippc disk and reinstalled the software.After which, the system was returned to use in good working order.The codes were updated based on the investigation outcome.The device problem code and component code were corrected.
 
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Brand Name
ALLURA XPER FD
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 Key16565447
MDR Text Key311563971
Report Number3003768277-2023-01699
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00884838059030
UDI-Public00884838059030
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K130638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
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 FD10
Device Catalogue Number722010
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/01/2023
Initial Date FDA Received03/17/2023
Supplement Dates Manufacturer Received09/18/2023
Supplement Dates FDA Received10/31/2023
Was Device Evaluated by Manufacturer? Yes
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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