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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20
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PHILIPS HEALTHCARE ALLURA XPER FD20 Back to Search Results
Model Number 722012
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Philips received a complaint from a customer that the x-ray did not work.
 
Manufacturer Narrative
(b)(4).The field svc engineer (fse)'s visual review of the system showed the footswitch was bent and not working properly.Philips conducted its investigation based on info received.Based on available info, the cause could be related to the use of anti-fatigue mats under the footswitches since the footswitch was designed to be used on a solid surface.After replacing the footswitch, the reported problem with the system was solved.Philips is working on adding a metal plate under the footswitch to prevent bending.
 
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Brand Name
ALLURA XPER FD20
Manufacturer (Section D)
PHILIPS HEALTHCARE
veenpluis 4-6
best 5680 DA
NL  5680 DA
Manufacturer (Section G)
PHILIPS HEALTHCARE
veenpluis 4-6
best 5680 DA
NL   5680 DA
Manufacturer Contact
dominic siewko
300 minuteman rd
ms 4-235
andover, MA 01810
9786597936
MDR Report Key4088488
MDR Text Key4763281
Report Number3003768277-2014-00094
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K033737
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number722012
Device Catalogue Number722012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/15/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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