BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KION

    MDR report key: 300615 · Received October 13, 2000

    Report

    Report Number
    8010042-2000-00147
    Event Type
    Malfunction
    Date Received
    October 13, 2000
    Report Date
    September 29, 2000
    Manufacturer
    SIEMENS ELEMA AB / LIFE SUPPORT SYSTEMS DIVISION
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SAFETY VALVE SV1 180 KPK SPORADICALLY OPEN WITH A FRESH GAS FLOW OF 0.5 LITERS FOR THEREAFTER OPEN COMPLETELY WITH A FRESH GAS FLOW OF 1 LITERS FOLLOWED BY BANGING NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KION ANESTHESIA SYSTEM BSZ SIEMENS ELEMA AB / LIFE SUPPORT SYSTEMS DIVISION KION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA