BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIRRUS

    MDR report key: 379227 · Received February 25, 2002

    Report

    Report Number
    2916556-2002-00007
    Event Type
    Other
    Date Received
    February 25, 2002
    Date of Event
    January 30, 2002
    Report Date
    January 31, 2002
    Manufacturer
    ADAC LABORATORIES
    Product Code
    KPS
    Removal / Correction Number
    011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ADAC THAT A PIN HOLE COLLIMATOR DISENGAGED FROM THE DETECTOR. A PATIENT WAS PRESENT AT THE TIME OF THE INCIDENT. THE PATIENT REQURED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRRUS NUCLEAR MEDICINE EQUIPMENT KPS ADAC LABORATORIES 2145-3010B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention