BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KION

    MDR report key: 3980208 · Received June 5, 2014

    Report

    Report Number
    8010042-2014-00247
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K024213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN THE INVESTIGATION HAS BEEN FINALIZED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL WALL GAS SUPPLY DROPPED AND THE ANESTHESIA WORKSTATION STOPPED VENTILATING THE PATIENT. CONNECTING THE ANESTHESIA WORKSTATION TO ANOTHER WALL SUPPLY HELPED ONLY AFTER A RESTART OF THE ANESTHESIA WORKSTATION. NO HARM TO THE PATIENT WAS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330420 KION BSZ MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1