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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; SYSTEM, X-RAY, ANGIOGRAPHIC
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; SYSTEM, X-RAY, ANGIOGRAPHIC Back to Search Results
Model Number ALLURA XPER FD20 OR TABLE
Device Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2024
Event Type  malfunction  
Event Description
It was reported to philips that the device's host computer was crashing during startup.The device was clinical use at the time of reported event.No harm was reported to philips.Philips has started an investigation of this complaint.
 
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Brand Name
ALLURA XPER FD
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 Key19203464
MDR Text Key341290379
Report Number3003768277-2024-02506
Device Sequence Number1
Product Code IZI
UDI-Device Identifier00884838059085
UDI-Public00884838059085
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K130842
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 FD20 OR TABLE
Device Catalogue Number722023
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/21/2024
Initial Date FDA Received04/29/2024
Date Device Manufactured08/07/2013
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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