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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 FD10
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2024
Event Type  malfunction  
Event Description
It was reported to philips that the table side operating module's command knobs have failed, which can impact geometry movements.The device was in clinical use at the time of the event.No patient or user harm was reported.Philips has started an investigation of the 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
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NL  5684 PC
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
veenpluis 6
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NL   5684 PC
Manufacturer Contact
derrick massuri
3000 minuteman rd
andover, MA 01810
6172455900
MDR Report Key18921348
MDR Text Key337868151
Report Number3003768277-2024-01836
Device Sequence Number1
Product Code IZI
UDI-Device Identifier00884838059030
UDI-Public00884838059030
Combination Product (y/n)N
Reporter Country CodeAR
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 Biomedical Engineer
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2024
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 Number722010
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2024
Date Device Manufactured11/28/2012
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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