BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARGUS

    MDR report key: 264578 · Received February 21, 2000

    Report

    Report Number
    2916556-2000-00239
    Event Type
    Other
    Date Received
    February 21, 2000
    Date of Event
    January 21, 2000
    Report Date
    February 14, 2000
    Manufacturer
    ADAC LABORATORIES
    Product Code
    KPS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ADAC WAS NOTIFIED BY A BIOMED AT THE HOSP THAT THE SAFETY EMERGENCY STOP SWITCH ON THE DISPLAY PANEL WAS BYPASSED BY A THIRD PARTY SVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGUS NUCLEAR MEDICINE EQUIPMENT KPS ADAC LABORATORIES 2145-3003E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *