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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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PHILIPS HEALTHCARE ALLURA XPER FD20; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 722012
Device Problem Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
When the investigation has been completed philips will inform the fda.
 
Event Description
It has been reported to philips that there was smoke coming from the x-ray generator.The system was not in clinical use at the time of this incident.No patient was in the room.Philips has started an investigation of this complaint.
 
Manufacturer Narrative
Philips has investigated this complaint.It was reported that technicians smelled smoke while the system was not in clinical use.A fire alarm went off due to the smoke and the fire department was called on site.They evacuated the room and flipped the breakers.No power fluctuations with the hospital mains supply were reported.No harm was reported to philips.Philips confirmed that the root cause of the issue is that the capacitors inside the converter failed.Converters are ul 94 certified, and therefore any possible fire will self-extinguish.The converter was replaced with a new converter which is much more robust against mains disturbances and will prevent early failure of the converter.The system was returned to use in good working order.Philips has opened an investigation as a follow up for the noted complaint.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
Event Description
It has been reported to philips that there was smoke coming from the x-ray generator.The system was not in clinical use at the time of this incident.No patient was in the room.Philips has started an investigation of this complaint.
 
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Brand Name
ALLURA XPER FD20
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
PHILIPS HEALTHCARE
veenpluis 4-6
p.o. box 10.000
best 5680 DA
NL  5680 DA
MDR Report Key9081676
MDR Text Key161812590
Report Number3003768277-2019-00072
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
PMA/PMN Number
K033737
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number722012
Device Catalogue Number722012
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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