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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20 OR TABLE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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PHILIPS HEALTHCARE ALLURA XPER FD20 OR TABLE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 722035
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 is completed, a follow-up report will be sent to the fda.
 
Event Description
It has been reported to philips that while preparing the room for an examination, the cover of the l-arm of the system detached.No harm to the patient has been reported to philips.
 
Manufacturer Narrative
Philips has investigated this complaint.Philips checked the system on site and confirmed that the safety chain used to prevent the circular cover from falling off was deformed.The deformation was corrected and the cover was re-attached.The system was returned to use in good working order.Since then, the issue has not reoccurred.No harm has been reported to philips.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 OR TABLE
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 Key8830422
MDR Text Key152669279
Report Number3003768277-2019-00061
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
PMA/PMN Number
K141979
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number722035
Device Catalogue Number722035
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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