BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL SYSTEMS

    MDR report key: 1813733 · Received August 19, 2010

    Report

    Report Number
    MW5017178
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 19, 2010
    Manufacturer
    PHILIPS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS IS A PHILIPS DIAGNOST ELEVA FLUOROSCOPY AND RADIOLOGY MACHINE. THE TABLE WAS IN A HORIZONTAL POSITION WITH AN ELDERLY PT ON THE TABLE. THE PT'S GRANDDAUGHTER HAD BEEN STANDING BY THE BUCKY SIDE OF THE TABLE HELPING SOOTHE PT WHILE X-RAYS WERE BEING DONE. THE GRANDDAUGHTER HAD JUST MOVED TO THE HEAD OF THE TABLE WHEN THE BUCKY SHOT OPEN AND EJECTED THE CASSETTE WITHOUT PROMPTING OR WARNING. THIS CASSETTE FLEW APPROXIMATELY 5 OR MORE FEET AND HIT THE CABINETS ON THE WALL ACROSS THE ROOM. THERE WAS QUITE A BIT OF FORCE FOR THIS TO TRAVEL THIS FAR. THIS HAS BEEN REPORTED TO PHILIPS, ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS DIAGNOST ELEVA X-RAY/FLUOROSCOPY UNIT JAA PHILIPS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other