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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLURA XPER FD; SYSTEM, X-RAY, ANGIOGRAPHIC
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ALLURA XPER FD; SYSTEM, X-RAY, ANGIOGRAPHIC Back to Search Results
Model Number ALLURA XPER FD20
Device Problem Radiation Overexposure (3017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
Event Type  malfunction  
Event Description
It has been reported to philips that during a patient procedure the trigger level for the maximum dose level was exceeded.No harm to the patient was reported.Philips has started an investigation of this complaint.
 
Manufacturer Narrative
Philip has investigated this complaint.Philips checked the system onsite and analyzed the log files and no malfunction was found.The patient (weight: 170 kg) received a cumulative dose of 17 gy during two procedures ((b)(6) 2021).Based on the investigation performed, the high dose was the result of the number of images taken and the patient weight.
 
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Brand Name
ALLURA XPER FD
Type of Device
SYSTEM, X-RAY, ANGIOGRAPHIC
MDR Report Key11783065
MDR Text Key249238691
Report Number3003768277-2021-10015
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 Date05/03/2021
Initial Date Manufacturer Received 04/06/2021
Initial Date FDA Received05/06/2021
Supplement Dates Manufacturer Received04/06/2021
Supplement Dates FDA Received07/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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