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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20; INTERVENTIONAL FLUROSCOPIC X-RAY SYSTEM
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PHILIPS HEALTHCARE ALLURA XPER FD20; INTERVENTIONAL FLUROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 722012
Device Problems Bent (1059); Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Philips received a complaint from a customer that the footswitch was not working.
 
Manufacturer Narrative
(b)(4).The field service engineer (fse)'s visual review of the system showed the footswitch was bent and not working properly.Philips conducted its investigation based on information received.Based on available information, 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
Type of Device
INTERVENTIONAL FLUROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
PHILIPS HEALTHCARE
veenpluis 4-6
best 5680 DA
NL  5680 DA
Manufacturer Contact
wayne mycko
3000 minuteman rd
andover, MA 01810
9786594498
MDR Report Key4680421
MDR Text Key16076408
Report Number3003768277-2015-00027
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
Reporter Country CodeCH
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 Health Professional
Type of Report Initial
Report Date 03/13/2015
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 Number722012
Device Catalogue Number722012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/13/2015
Initial Date FDA Received04/08/2015
Was Device Evaluated by Manufacturer? Yes
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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