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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; SYSTEM X-RAY ANGIOGRAPHIC
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PHILIPS HEALTHCARE ALLURA XPER FD10; SYSTEM X-RAY ANGIOGRAPHIC Back to Search Results
Model Number 722003
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 FD10
Type of Device
SYSTEM X-RAY ANGIOGRAPHIC
Manufacturer (Section D)
PHILIPS HEALTHCARE
veenpluis 4-6
best 5680 DA
NL  5680 DA
Manufacturer Contact
deborah thurston
3000 minuteman rd
andover, MA 01810
9786592010
MDR Report Key4620410
MDR Text Key5652912
Report Number3003768277-2015-00023
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031333
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 02/20/2015
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 Number722003
Device Catalogue Number722003
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/20/2015
Initial Date FDA Received03/18/2015
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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