BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRIGHTVIEW SPECT

    MDR report key: 2492387 · Received March 13, 2012

    Report

    Report Number
    2916556-2012-00008
    Event Type
    Other
    Date Received
    March 13, 2012
    Report Date
    February 13, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC
    Product Code
    KPS
    PMA / PMN Number
    K062298
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT THAT AN UNTRAINED CT TECHNOLOGIST ASSISTING IN THE NUCLEAR MEDICINE DEPARTMENT PLACED HER ARM BETWEEN DETECTORS AS THEY CLOSED DURING 90 PPM MOTION (IN AN ATTEMPT TO RECONNECT CARDIAC MONITOR LEADS WHICH HAD BECOME DISCONNECTED FROM PT). THE DETECTORS DID NOT STOP SHY OF COMPLETING MOTION, ASSUME A COLLISION OR E-STOP DID OCCUR. A NUCLEAR MEDICINE TECHNOLOGIST COULD NOT FIND A SAFE WAY TO MOVE DETECTORS AWAY FROM CT TECH'S ARM. CT TECH'S ARM WAS LUBED UP AND A PRY BAR WAS USED TO INCREASE THE GAP ENOUGH TO EXTRACT HER ARM. THE TECH SUSTAINED BRUISING AND DID GO TO THE EMERGENCY ROOM. REPORTS BY THE IMAGING DEPARTMENT STAFF STATES THAT THE X-RAYS PERFORMED ON THE TECHNOLOGIST ARM DID NOT REVEAL ANY BREAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIGHTVIEW SPECT GAMMA CAMERA SYSTEM KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC 882480

    Patients

    Seq Age Sex Outcome Treatment
    1