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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 FD20
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/24/2023
Event Type  malfunction  
Event Description
It has been reported to philips that the live screen was faulty.The system was in clinical use.No harm has been reported to philips.A philips service engineer inspected the system on site and found that the display did not lit up.Troubleshooting actions showed a problem with exam room monitor.The fse replaced exam room monitor and the system was returned to use in good working order.
 
Manufacturer Narrative
Philips has investigated this complaint.The philips field service engineer (fse) inspected the system onsite and confirmed that the system live screen is faulty.Trouble shooting action showed that the monitor failed and there was no display.Fse replaced the monitor, and the system was returned to use in good working order.The codes were updated based on the investigation outcome.Evaluation method code was 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
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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 Key16860379
MDR Text Key314459433
Report Number3003768277-2023-02642
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00884838059054
UDI-Public00884838059054
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 FD20
Device Catalogue Number722012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/24/2023
Initial Date FDA Received05/03/2023
Supplement Dates Manufacturer Received05/17/2023
Supplement Dates FDA Received09/20/2023
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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