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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ALLURA XPER FD20/15 OR TABLE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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PHILIPS MEDICAL SYSTEMS ALLURA XPER FD20/15 OR TABLE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 722059
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/17/2018
Event Type  malfunction  
Event Description
St-elevation myocardial infarction (stemi) patient was on x-ray; table: x-ray.Table was unable to move, frozen error message about geometry is resting, attending was unable to cine: catheter, wire where in patient when room starting to reboot.Need an override to prevent it in future.There is the possibility that the emergency stop button was pushed inadvertently which would cause this event.Bmet and philips service were contacted to service room and review error messages for potential causes.
 
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Brand Name
ALLURA XPER FD20/15 OR TABLE
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
595 miner road
cleveland OH 44143
MDR Report Key7634064
MDR Text Key112218410
Report Number7634064
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00884838059122
UDI-Public(01)00884838059122
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number722059
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2018
Event Location Hospital
Date Report to Manufacturer06/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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