BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRIGHTVIEW X

    MDR report key: 2933173 · Received January 24, 2013

    Report

    Report Number
    1525965-2013-00010
    Event Type
    Other
    Date Received
    January 24, 2013
    Report Date
    January 11, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K062298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHILIPS SERVICE ENGINEER EVALUATED THE SYSTEM AFTER THE REPORTED EVENT AND DETERMINED THAT THE SYSTEM DID NOT MALFUNCTION. A LOG FILE REVIEW SHOWED NO MALFUNCTION. THERE WAS NO DAMAGE TO THE SYSTEM AND THUS, NO REPAIRS WERE MADE AND WAS OPERATING AS DESIGNED. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFO WHERE A CUSTOMER REPORTED THAT DURING A CARDIAC GATED STRESS SPECT, THE PT BECAME CONCERNED THAT HIS IV MAY COME OUT, SO THEY MOVED HIS HANDS DOWN TO CHECK THE IV. AFTER CHECKING HIS IV, THE PT MOVED HIS HANDS BACK INTO POSITION AS THE DETECTORS WERE MOVING INTO THE START POSITION WHEN THE PT'S LEFT WRIST GOT CAUGHT IN BETWEEN THE TWO DETECTORS AS THE DETECTORS WERE MOVING INTO HIS FINAL POSITION. THIS MOVEMENT CAUSED THE COLLISION SENSORS TO APPROPRIATELY GO OFF ON THE SYSTEM. THE PT COMPOSED THEMSELVES AND INSISTED ON COMPLETING THE STUDY. THE PT WAS RE-POSITIONED AND SCANNED WITHOUT ANY INCIDENT. THE PT DID RECEIVE BRUISING AND ABRASIONS AS A RESULT OF THE REPORTED EVENT AND WAS TAKEN FOR X-RAYS. THE X-RAY INDICATED THAT THE PT DID NOT HAVE ANY BROKEN BONES FROM THE RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34910 BRIGHTVIEW X KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 882480

    Patients

    Seq Age Sex Outcome Treatment
    1