MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ALLURA XPER FD20/15 OR TABLE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	722059
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Event or Problem 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.

• Brand Name: ALLURA XPER FD20/15 OR TABLE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 595 miner road; cleveland OH 44143
• MDR Report Key: 7634064
• Report Number: 7634064
• Device Sequence Number: 1555357
• Product Code: OWB
• UDI-Device Identifier: 00884838059122
• UDI-Public: (01)00884838059122
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/05/2018
• Report Date (Section F): 06/05/2018

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
• Operator of Device: Health Professional
• Device Model Number: 722059
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/05/2018