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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC Back to Search Results
Model Number ALLURA XPER FD10
Device Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2023
Event Type  malfunction  
Event Description
It was reported to philips that the allura system did not start.The device was outside of clinical use at the time of the reported event, no harm was reported to philips.As per the field service engineer, the host pc was not starting, and they had to reboot it manually.Philips has started an investigation of this complaint.
 
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Brand Name
ALLURA XPER FD10
Type of Device
SYSTEM, X-RAY, ANGIOGRAPHIC
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 Key18409843
MDR Text Key331514832
Report Number3003768277-2023-07246
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K041949
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
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 Number722003
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/21/2023
Initial Date FDA Received12/28/2023
Date Device Manufactured09/23/2005
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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