BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVICE REP,C/U,INTELIJET,120V

    MDR report key: 382060 · Received March 4, 2002

    Report

    Report Number
    1643264-2002-00009
    Event Type
    Malfunction
    Date Received
    March 4, 2002
    Date of Event
    February 4, 2002
    Report Date
    February 4, 2002
    Manufacturer
    SMITH & NEPHEW, INC. - ENDOSCOPY DIV
    Product Code
    KQT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO SURGERY THE INTELIJET WAS EXCEEDING THE SET PRESSURE. AS THIS INCIDENT OCCURRED PRIOR TO SURGERY THERE WERE NO PT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVICE REP,C/U,INTELIJET,120V ENDOSCOPIC FLUID MANAGEMENT PUMP KQT SMITH & NEPHEW, INC. - ENDOSCOPY DIV 4350H *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN