BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEM FLEX SOLO II PET SCANNER

    MDR report key: 1060005 · Received June 10, 2008

    Report

    Report Number
    3005945241-2008-00001
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    May 16, 2008
    Report Date
    June 9, 2008
    Manufacturer
    NAVISCAN PET SYSTEMS, INC.
    Product Code
    KPS
    PMA / PMN Number
    K032063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING ROOT CAUSE INVESTIGATION OF THE INCIDENT, NAVISCAN IDENTIFIED ADDITIONAL FAILURE MODE RELATED TO MECHANICAL FAULT PROTECTION. ON 6/6/08, NAVISCAN PERFORMED A RISK ASSESSMENT AND DETERMINED THAT THIS INCIDENT IS REPORTABLE AS AN MDR AS DEFINED BY 21 CFR 803.

    Description of Event or Problem · 1

    TECH REPORTED THAT THE "C-PADDLE" MOVED DOWNWARD WHEN THE FOOTSWITCH "DOWN" SWITCH WAS PRESSED WHILE POSITIONING PT'S BREAST FOR SCAN. WHEN TECH RELEASED "DOWN" SWITCH, "C-PADDLE" CONTINUED DOWNWARD MOVEMENT, STOPPING AFTER TECH PRESSED "UP" SWITCH ON CONTROL PANEL. PT REPORTED EXCESSIVE PAIN DUE TO COMPRESSION. AFTER MOVEMENT WAS STOPPED, PT WAS POSITIONED FOR COMPLETION OF SCAN WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEM FLEX SOLO II PET SCANNER PET SCANNER KPS NAVISCAN PET SYSTEMS, INC. 00009022

    Patients

    Seq Age Sex Outcome Treatment
    1