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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 Device Stops Intermittently (1599); Computer Operating System Problem (2898)
Patient Problem No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
A philips service engineer on site found a damaged cable bundle.During lateral table movement the cabling is cut into by the metal structure resulting in leakage current to earth.Apparently the system detects this and cuts power to the module when the investigation has been completed philips will inform the fda patient.(b)(4).
 
Event Description
Philips received a complaint from the customer in which they stated that while a patient with a heart attack was on the table for a cardiovascular procedure, the system activated the emergency stop without interference from the user.The customer had to reboot the system and was able to stabilize the patient, the procedure was interrupted for approximately 5 minutes.After this the room was taken out of action until the issue was corrected.No patient harm was reported as a result of this issue,.
 
Manufacturer Narrative
Philips become aware date has been changed to (b)(6) 2016.The system detects this and cuts power to the module.
 
Manufacturer Narrative
Philips investigated this complaint and came to the following conclusion: it is assumed that because during lateral table movement the cabling is rubbing to the metal structure, eventually the cable is cut.When a cable is damaged, it will cause reduced functionality, which will be reported when detected, in which case the affected cable set will be replaced.Analysing the possible cable cuts and the effect on the patient of these different failures, shows that what can worst case happen is that motorized movement is not possible anymore, and the current procedure needs to be ended prematurely.Ending the procedure can still be done safely, as basic imaging functionality keeps working.
 
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Brand Name
ALLURA XPER FD10
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 (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
dusty leppert
veenpluis 4-6
p.o. box 10.000
best 5680 -DA
NL   5680 DA
MDR Report Key5897961
MDR Text Key53679155
Report Number3003768277-2016-00078
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K041949
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 08/04/2016
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
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/08/2016
Initial Date FDA Received08/23/2016
Supplement Dates Manufacturer ReceivedNot provided
08/04/2016
Supplement Dates FDA Received08/29/2016
08/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2008
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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