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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 03/04/2024
Event Type  malfunction  
Event Description
It was reported to philips that host pc memory 3 was not available.The device was in clinical use at the time of the reported event.No harm was reported to philips.Philips has started an investigation of this complaint.
 
Manufacturer Narrative
Philips has investigated this complaint.A philips field service engineer (fse) examined the system onsite and confirmed host pc memory 3 problem occurred during runtime.The defective part was returned for analysis, for flex vision pc no failure was observed.However, the replacement of the host pc in the main cabinet of the system and performing successful functional tests by the fse has resolved the reported issue.After the replacement, the system returned to use in good working order.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
derrick massuri
3000 minuteman rd
andover, MA 01810
6172455900
MDR Report Key18855179
MDR Text Key337102575
Report Number3003768277-2024-01605
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00884838054202
UDI-Public00884838054202
Combination Product (y/n)N
Reporter Country CodeIT
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 Number722028
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/04/2024
Initial Date FDA Received03/07/2024
Supplement Dates Manufacturer Received05/03/2024
Supplement Dates FDA Received05/06/2024
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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