BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARC

    MDR report key: 238135 · Received August 27, 1999

    Report

    Report Number
    2916556-1999-00085
    Event Type
    Malfunction
    Date Received
    August 27, 1999
    Date of Event
    April 9, 1997
    Report Date
    April 9, 1997
    Manufacturer
    ADAC LABORATORIES
    Product Code
    JWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE DETECTOR ROTATED AT "HIGH SPEED" AROUND THE PT AND APPEARED TO DRIFT TOWARD THE PT DURING A STATIC STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARC NUCLEAR MEDICINE EQUIPMENT JWM ADAC LABORATORIES 2129-3015A *

    Patients

    Seq Age Sex Outcome Treatment
    1 *