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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA ZPER FD20
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PHILIPS HEALTHCARE ALLURA ZPER FD20 Back to Search Results
Model Number 722028
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Philips received a complaint from manufacturing from the ixr best manufacturing plant, that as result of a faulty automatic motor controller, a problem in error handling during startup of the system (post of positioning software) was detected which can result in a hazardous movement.
 
Manufacturer Narrative
(b)(4).When investigation is completed a f/u report will be sent to the fda.
 
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Brand Name
ALLURA ZPER FD20
Manufacturer (Section D)
PHILIPS HEALTHCARE
veenpluis 4-6
best 5680 DA
NL  5680 DA
Manufacturer (Section G)
PHILIPS HLTHCARE
veenpluis 4-6
best 5680 DA
NL   5680 DA
Manufacturer Contact
dominic siewko
3000 minuteman rd
ms 4-135
andover, MA 01810
9786597936
MDR Report Key3922489
MDR Text Key4517800
Report Number3003768277-2014-00059
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K031333
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 05/20/2014
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 Number722028
Device Catalogue Number722028
Device Lot NumberNOT RELEVANT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/16/2014
Initial Date FDA Received06/02/2014
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 Initial
Patient Sequence Number1
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