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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10/10
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PHILIPS HEALTHCARE ALLURA XPER FD10/10 Back to Search Results
Model Number 722011
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Philips received a complaint from a customer that system was down caused by host pc.The windows startup was intermittent.When the startup was successful during exposure the system would freeze and the exposure buzzer would go off.
 
Manufacturer Narrative
(b)(4).When investigation is completed, a follow up report will be sent to the fda.
 
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Brand Name
ALLURA XPER FD10/10
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
3000 minuteman rd
ms 4-135
andover, MA 01810
9786597936
MDR Report Key3838696
MDR Text Key4659589
Report Number3003768277-2014-00016
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K041949
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 02/12/2014
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 Number722011
Device Catalogue Number722011
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/12/2014
Initial Date FDA Received03/12/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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