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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 No Display/Image (1183)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2020
Event Type  malfunction  
Event Description
It has been reported to philips that during an emergency stent placement procedure the live signal on the flexvision monitor was lost.The procedure was completed after restarting the system.No harm to the patient or user was reported.Philips has started an investigation of this complaint.
 
Manufacturer Narrative
Philips has investigated this complaint.Philips has confirmed through inspection of the system onsite that the hard disk of the image processing pc failed.The hard disk 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 4-6
best 5684 PC
NL  5684 PC
MDR Report Key10834468
MDR Text Key216098200
Report Number3003768277-2020-01025
Device Sequence Number1
Product Code IZI
UDI-Device Identifier00884838059030
UDI-Public00884838059030
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 FD10
Device Catalogue Number722010
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date11/09/2020
Initial Date Manufacturer Received 10/19/2020
Initial Date FDA Received11/13/2020
Supplement Dates Manufacturer Received11/09/2020
Supplement Dates FDA Received03/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
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