BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE3

    MDR report key: 483687 · Received September 8, 2003

    Report

    Report Number
    2916556-2003-00014
    Event Type
    Malfunction
    Date Received
    September 8, 2003
    Date of Event
    April 23, 2002
    Report Date
    September 8, 2003
    Manufacturer
    ADAC LABORATORIES
    Product Code
    MUJ
    Removal / Correction Number
    2916566-05/15/02-013C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INITIAL EVENT REPORTED INDICATED SUPERIOR-INFERIOR IMAGE REVERSAL WHICH IS CONSIDERED UNLIKELY TO RESULT IN SERIOUS INJURY. HOWEVER, FURTHER INVESTIGATION REVEALED EVENT RESULTED IN A LEFT-RIGHT REVERSAL. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE3 RADIATION THERAPY PLANNING EQUIPMENT MUJ ADAC LABORATORIES 9200-0584B-ENG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA