BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRIGHTVIEW GAMMA CAMERA SYSTEM

    MDR report key: 2933172 · Received January 24, 2013

    Report

    Report Number
    1525965-2013-00009
    Event Type
    Other
    Date Received
    January 24, 2013
    Report Date
    January 2, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K062298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THERE WAS NO DAMAGE TO THE SYSTEM AND THUS NO REPAIRS WERE MADE AND WAS OPERATING AS DESIGNED. A LOG FILE REVIEW SHOWED NO MALFUNCTIONS. THE BIOMEDICAL ENGINEER USED A CROWBAR TO SEPARATE THE DETECTORS ENOUGH TO FREE THE OPERATOR'S ARM, AS THERE WAS SOME CONFUSION ON THE CUSTOMER'S PART ABOUT PUTTING THE SYSTEM IN OVERRIDE AND MANUALLY MOVING THE DETECTORS APART WHEN IN COLLISION MODE. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFO WHERE A CUSTOMER REPORTED THE OPERATOR GOT HER ARM CAUGHT BETWEEN THE DETECTOR HEADS DURING THE SET-UP OF A CARDIAC ACQUISITION. THE COLLISION SENSORS ACTIVATED AND HALTED ALL SYSTEM MOTION, HOWEVER, THE OPERATOR WAS UNABLE TO FREE HER ARM DUE TO THE POSITION OF THE DETECTORS WITHOUT THE HELP FROM THE SITE'S BIOMEDICAL ENGINEER. THE OPERATOR WAS EVALUATED IN THE EMERGENCY DEPARTMENT AND REPORTED LOCALIZED BRUISING, BUT DID NOT SUSTAIN A FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34896 BRIGHTVIEW GAMMA CAMERA SYSTEM KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 2170-3000A

    Patients

    Seq Age Sex Outcome Treatment
    1