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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
Device Problem Radiation Output Failure (4027)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2020
Event Type  malfunction  
Event Description
It was reported to philips that during an emergency procedure the system couldn't expose.The procedure was aborted.No harm to patient or user has been reported to philips.Philips has started an investigation of this complaint.
 
Manufacturer Narrative
Philips has investigated the complaint.Philips has confirmed through inspection of the system onsite and the analysis of the log file that the hard disks of the image processing pc failed.The hard disks were 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 4-6
best 5684 PC
NL  5684 PC
MDR Report Key11176222
MDR Text Key227011774
Report Number3003768277-2021-00008
Device Sequence Number1
Product Code IZI
UDI-Device Identifier00884838059054
UDI-Public00884838059054
Combination Product (y/n)N
PMA/PMN Number
K130842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
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
Device Catalogue Number722012
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date12/16/2020
Initial Date Manufacturer Received 12/17/2020
Initial Date FDA Received01/15/2021
Supplement Dates Manufacturer Received12/16/2020
Supplement Dates FDA Received04/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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