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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ALLURA XPER; SYSTEM, X-RAY, ANGIOGRAPHIC
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PHILIPS MEDICAL SYSTEMS ALLURA XPER; SYSTEM, X-RAY, ANGIOGRAPHIC Back to Search Results
Device Problems Thermal Decomposition of Device (1071); Fire (1245); Nonstandard Device (1420)
Patient Problem No Patient Involvement (2645)
Event Date 04/10/2017
Event Type  malfunction  
Event Description
Friday morning, our phillips equipment was turned on in cath lab room 2.Shortly after booting up the system, the staff smelled burning plastic.The fire alarms automatically went off.One of the electrical panels for the phillips equipment had caught fire.The emergency button was hit to shut down all power to room.The (b)(6) fire department arrived and assessed the situation.Room 2 is down for repairs.We were recently notified of a recall of the equipment in the last month.Manufacturer response for electrical, (brand not provided) (per site reporter): this event is the direct result of a recent alert/recall issued by the vendor.The vendor has taken responsibility for the event and all costs associated with the repair.The system will be out of service for 2 weeks for repair.
 
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Brand Name
ALLURA XPER
Type of Device
SYSTEM, X-RAY, ANGIOGRAPHIC
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
595 miner road
cleveland OH 44143
MDR Report Key6683918
MDR Text Key78957472
Report Number6683918
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/09/2017
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 No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/09/2017
Event Location Hospital
Date Report to Manufacturer06/09/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
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