BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MS16A SYRINGE DRIVER

    MDR report key: 520580 · Received February 4, 2004

    Report

    Report Number
    9612511-2004-00004
    Event Type
    Malfunction
    Date Received
    February 4, 2004
    Date of Event
    August 31, 2002
    Report Date
    February 3, 2004
    Manufacturer
    GRASEBY MEDICAL LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DIAMORPHINE PUMP FOUND TO BE EMTPY AT MORNING SHIFT HANDOVER. INFUSION WAS CHANGED AT 01.00 HRS AND SHOULD RUN OVER 24HRS. DOCTOR ON CALL NOTIFIED-UNKNOWN OUTCOME AND NO REPORTED ADVERSE CONSEQUENCES TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MS16A SYRINGE DRIVER SYRINGE DRIVER FRN GRASEBY MEDICAL LTD. MS16A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention