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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 Problem Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2023
Event Type  malfunction  
Event Description
It has been reported to philips that bootup gets stuck at "select boot device." the system was not in clinical use at this time and there was no reported patient or user harm.The philips technician explained to customer how to fully boot the system.
 
Manufacturer Narrative
Philips has investigated this complaint.The philips remote service engineer (rse) communicated with the customer and confirmed that the system's booting process was stuck at 'select boot device'.A review of the system log file didn¿t confirm the reported problem.Upon remote testing, the rse explained some workaround steps to the customer to proceed with the startup by pressing 'sata' followed by 'enter¿.After the workaround steps provided the issue didn¿t reoccur and the system was 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 Key18581102
MDR Text Key333823147
Report Number3003768277-2024-00424
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00884838054189
UDI-Public00884838054189
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K162859
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 Number722026
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/25/2024
Supplement Dates Manufacturer Received02/16/2024
Supplement Dates FDA Received02/19/2024
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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