BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIGHTVIEW GAMMA CAMERA SYSTEM

    MDR report key: 3911512 · Received May 27, 2014

    Report

    Report Number
    1525965-2014-00110
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    April 28, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K062298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IN THIS CASE THE FIELD SERVICE ENGINEER (FSE) REPORTED THE DISCOVERY OF LOOSE DETECTOR MOUNTING BOLTS (2) DURING ROUTINE PLANNED MAINTENANCE (PM) ON A BRIGHTVIEW CAMERA. THERE WAS NO REPORT OF HARM TO A PATIENT, OPERATOR, OR BYSTANDER. THE FSE STATED THAT THERE WAS NO RESCAN OR REINJECTION OF A PATIENT. THE FSE TIGHTENED THE BOLTS, EXAMINED ALL OTHER MOUNTING BOLTS, AND COMPLETED THE PM PER THE "BRIGHTVIEW PLANNED MAINTENANCE MANUAL BEFORE RETURNING THE SYSTEM TO CLINICAL USE. THERE WAS NO HARM AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311019 BRIGHTVIEW GAMMA CAMERA SYSTEM KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 882480

    Patients

    Seq Age Sex Outcome Treatment
    1