BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 2181933 · Received May 8, 2008

    Report

    Report Number
    3003768277-2008-00055
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 8, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (EVAL METHOD, RESULTS, CONCLUSIONS): THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. NOTE THE INDICATED IMPORTER HAS RECEIVED FDA EXEMPTION NUMBER, (B)(4) TO SUBMIT ONE FDA FORM 3500A TO SATISFY BOTH THE IMPORTER (B)(4) AND MANUFACTURER (B)(4) FOR THE SAME EVENT.

    Description of Event or Problem · 1

    DURING A PT'S X-RAY CARDIOVASCULAR PROCEDURE, ONE OF THE HOSPITAL STAFF WAS MOVING THE DEVICE'S MONITOR SUSPENSION WHEN IT SUDDENLY FELL FROM ITS CEILING MOUNT. THE STAFF MEMBER TRIED TO SLOW THE MONITOR'S FALL. THE MONITOR BOLTS CONNECTING THE ADJUSTABLE VERTICAL COLUMN TO THE CONNECTION PIECE PULLED OUT OF THEIR THREADS ALLOWING THE COLUMN AND MONITOR ASSEMBLY TO FALL. ALUMINUM SHAVINGS WERE SCATTERED ON THE PT REQUIRING REDRAPING OF THE STERILE DRAPE. THE MONITORS DID NOT HIT THE FLOOR BUT REMAINED SUPPORTED BY THE CABLE DRAPE. THE STAFF MEMBER AND PT WERE NOT INJURED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD20 IZI (ANGIOGRAPHIC X-RAY SYSTEM) IZI PHILIPS MEDICAL SYSTEMS 722006 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA