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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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PHILIPS HEALTHCARE ALLURA XPER FD10; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 722010
Device Problems Break (1069); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still ongoing for this event.When the investigation is completed a follow-up will be sent to the fda.
 
Event Description
It has been reported to philips that the cover of the c-arm came loose.The safety chain was broken and the cover fell down away from the patient table.No harm to the patient has been reported to philips.Philips has started an investigation for this complaint.
 
Manufacturer Narrative
Philips has investigated this complaint.Philips has confirmed with the customer that no harm had occurred to the patient or to any user or bystander and the procedure was completed successfully.Philips has inspected the system on site and identified that the glue of the rubber blocks, which hold the l-arm rotation cover, had come loose.The rubber blocks were reinstalled with screws and the cover was reattached.The system was returned to use in good working order.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 FD10
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 Key10401147
MDR Text Key203518996
Report Number3003768277-2020-00049
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
PMA/PMN Number
K130638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number722010
Device Catalogue Number722010
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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