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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 FD20
Device Problem Unintended System Motion (1430)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2020
Event Type  malfunction  
Event Description
It was reported to philips that during diagnostic coronary procedure the c-arm started moving without a valid command from the user.No harm to patient or user has been reported to philips.Philips has started an investigation of this complaint.
 
Manufacturer Narrative
Philips has investigated this complaint.According to the information collected, the problem occurred after completing a pacemaker implantation procedure.To stop the movement of the system, the user pressed the emergency stop button.A philips engineer inspected the system onsite and identified that the geometry module failed.The geometry module 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 Key11124004
MDR Text Key225299919
Report Number3003768277-2021-00003
Device Sequence Number1
Product Code IZI
UDI-Device Identifier00884838059054
UDI-Public00884838059054
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,health
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 FD20
Device Catalogue Number722012
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date12/08/2020
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received01/06/2021
Supplement Dates Manufacturer Received12/08/2020
Supplement Dates FDA Received04/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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