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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 07/13/2023
Event Type  malfunction  
Event Description
It was reported to philips that there was a problem with the monitor.No harm was reported.We are conservatively reporting this event as the investigation is ongoing.A follow up report will be submitted when further information is received.
 
Manufacturer Narrative
Philips has investigated this complaint.Customer reported there was a monitor fluoroscopy problem.Remote service engineer (rse) called and analyzed the system.Rse suggested onsite service.Customer refused the quotation of onsite service from philips.Since the quotation has been cancelled and no service has been provided from the philips.To date, no further information was received.The codes were updated based on the investigation outcome.
 
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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 Key17490904
MDR Text Key321321878
Report Number3003768277-2023-04350
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00884838054202
UDI-Public00884838054202
Combination Product (y/n)N
Reporter Country CodeID
PMA/PMN Number
K161563
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 Number722028
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/13/2023
Initial Date FDA Received08/09/2023
Supplement Dates Manufacturer Received11/10/2023
Supplement Dates FDA Received12/29/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2017
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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