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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD20; SYSTEM, X-RAY, ANGIOGRAPHIC
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PHILIPS HEALTHCARE ALLURA XPER FD20; SYSTEM, X-RAY, ANGIOGRAPHIC Back to Search Results
Model Number 722006
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The customer reported to philips that the footswitch was not working.
 
Manufacturer Narrative
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.(b)(4).
 
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Brand Name
ALLURA XPER FD20
Type of Device
SYSTEM, X-RAY, ANGIOGRAPHIC
Manufacturer (Section D)
PHILIPS HEALTHCARE
veenpluis 4-6
p.o. box 10.000
best 5680 DA
NL  5680 DA
Manufacturer Contact
dusty leppert
veenpluis 4-6
p.o. box 10.000
best 5680 -DA
NL   5680 DA
MDR Report Key4758987
MDR Text Key17577638
Report Number3003768277-2015-00040
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 04/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number722006
Device Catalogue Number722006
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/14/2015
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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