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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE INTEGRIS ALLURA 15 & 12 (MONOPLANE); INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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PHILIPS HEALTHCARE INTEGRIS ALLURA 15 & 12 (MONOPLANE); INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 722043
Device Problem Device Inoperable (1663)
Patient Problem Heart Failure (2206)
Event Date 07/01/2015
Event Type  Injury  
Event Description
Philips was informed by the customer that the live monitor stopped working during a procedure.They temporarily plugged in another monitor to replace the live monitor and finished the procedure.During the exam, patient had a heart attack, the patient recovered from this heart attack procedure was finished in a controlled way.
 
Manufacturer Narrative
(b)(4).When investigation is completed a follow up report will be sent to fda.
 
Manufacturer Narrative
Philips investigated the issue and confirmed that the live monitor was defective.After replacement of the monitor the problem was solved.Philips will not take any further action.
 
Event Description
Philips was informed by the customer that the live monitor stopped working during a procedure.They temporarily plugged in another monitor to replace the live monitor and finished the procedure.During the exam, patient had a heart attack, the patient recovered from this heart attack procedure was finished in a controlled way.
 
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Brand Name
INTEGRIS ALLURA 15 & 12 (MONOPLANE)
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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 Key4960248
MDR Text Key6252025
Report Number3003768277-2015-00065
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K002016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,company representati
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 07/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number722043
Device Catalogue Number722043
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/10/2015
Initial Date FDA Received08/03/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/24/2015
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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