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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 722006
Device Problem Detachment of Device or Device Component (2907)
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 during preventive maintenance in the lab, the l-arm cover got detached.The cover was held by a safety chain and did not fall.Philips has started an investigation for this complaint.
 
Manufacturer Narrative
Philips investigated this complaint.Philips checked the system on site and confirmed that the safety chain used to prevent the l-arm cover from falling was intact.The cover was re-attached and the system was returned to use in good working order.Since then, the issue has not reoccurred.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.
 
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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 Key9144659
MDR Text Key175737621
Report Number3003768277-2019-00076
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 09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number722006
Device Catalogue Number722006
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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