BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCD-AC

    MDR report key: 238178 · Received August 27, 1999

    Report

    Report Number
    2916556-1999-00181
    Event Type
    Malfunction
    Date Received
    August 27, 1999
    Date of Event
    October 26, 1998
    Report Date
    October 26, 1998
    Manufacturer
    ADAC LABORATORIES
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE SAFETY SWITCH ON THE MCD-AC DOOR WAS DISABLED DUE TO THE RELIABILITY PROBLEMS WITH THE SYSTEM. THE SWITCH CAN FAIL TO MAKE CONTACT BECAUSE OF ISSUES WITH THE COVERS AND THE CABLE ROUTING CAN CAUSE INTERFERENCE WITH THE DRIVE ASSEMBLY. BOTH ISSUES CAN CAUSE THE SYSTEM TO HALT, CAUSING THE SYSTEM TO BE UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCD-AC NUCLEAR MEDICINE EQUIPMENT KPS ADAC LABORATORIES 2150-3062A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *