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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 FD20
Device Problem Electrical Shorting (2926)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2023
Event Type  malfunction  
Event Description
It has been reported to philips that there was a short circuit in the cabinet room which impacted the technical cabinet.The system is fully down.The system was not in clinical use.No harm has been reported to philips.Philips has started an investigation of this complaint.
 
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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 Key18592666
MDR Text Key333903609
Report Number3003768277-2024-00494
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00884838054202
UDI-Public00884838054202
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K033737
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
Date FDA Received01/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberALLURA XPER FD20
Device Catalogue Number722028
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/29/2023
Date Device Manufactured05/24/2017
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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