BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS

    MDR report key: 2943957 · Received January 23, 2013

    Report

    Report Number
    2943957
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 23, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STROKE PATIENT FROM ER BROUGHT TO INTERVENTIONAL RADIOLOGY FOR STROKE PROCEDURE; WHEN THE PHYSICIAN NEEDED TO OBTAIN FLUOROSCOPY, THE TUBE GENERATOR FAILED. THE PHILIPS NEURO MACHINE HAD TO BE REBOOTED TWICE BEFORE WE WERE ABLE TO OBTAIN FLUOROSCOPY. THIS CAUSED A DELAY IN PATIENT TREATMENT OF 15MIN.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VIR CAROTID CEREBRAL BILATERAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32684 INTEGRIS SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA PHILIPS MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR NO OTHER THERAPIES