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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 BIPLANE
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2023
Event Type  malfunction  
Event Description
It has been reported to philips that there was a power issue with the system.The system was not in clinical use at the time of the event.No harm has been reported to philips.A philips remote service engineer confirmed that the power supply was damaged.The power supply was replaced and the system was returned to use in good working order.
 
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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
best 5684 PC
NL   5684 PC
Manufacturer Contact
dusty leppert
3000 minuteman rd
andover, MA 01810
6172455900
MDR Report Key16636138
MDR Text Key312283719
Report Number3003768277-2023-01945
Device Sequence Number1
Product Code IZI
UDI-Device Identifier00884838059061
UDI-Public00884838059061
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
Reporter Occupation Physician
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 BIPLANE
Device Catalogue Number722013
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2023
Initial Date FDA Received03/29/2023
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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