BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KION

    MDR report key: 2253613 · Received September 8, 2011

    Report

    Report Number
    8010042-2011-00191
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Report Date
    August 16, 2011
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K024213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING, THE ANESTHESIA WORKSTATION GENERATED A HIGHER PRESSURE THAN SET. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1